{"id":"trifluridine-tipiracil","safety":{"commonSideEffects":[{"rate":"30-40%","effect":"Diarrhea"},{"rate":"20-30%","effect":"Fatigue"},{"rate":"20-30%","effect":"Nausea"},{"rate":"10-20%","effect":"Vomiting"},{"rate":"10-20%","effect":"Abdominal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Trifluridine-tipiracil is a combination of trifluridine and tipiracil. Trifluridine is a thymidine analog that inhibits thymidine kinase 1, which is necessary for DNA synthesis. Tipiracil is a thymidylate synthase inhibitor that helps to increase the levels of trifluridine in the body. This combination works synergistically to inhibit DNA synthesis in cancer cells, ultimately leading to cell death.","oneSentence":"Trifluridine-tipiracil is a thymidine kinase 1 inhibitor that also has a thymidylate synthase inhibitor component, which works by interfering with DNA synthesis in cancer cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:54:34.038Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic colorectal cancer"}]},"trialDetails":[{"nctId":"NCT07492173","phase":"NA","title":"Bioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans","status":"COMPLETED","sponsor":"Shandong New Time Pharmaceutical Co., LTD","startDate":"2022-11-21","conditions":"Solid Tumor Cancer","enrollment":76},{"nctId":"NCT07491159","phase":"PHASE1, PHASE2","title":"Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2023-07-01","conditions":"Colorectal Cancer","enrollment":106},{"nctId":"NCT07011550","phase":"PHASE2","title":"Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer","status":"SUSPENDED","sponsor":"M.D. Anderson Cancer Center","startDate":"2025-08-15","conditions":"Microsatellite-stable Colorectal Cancer, Standard of Care, Nivolumab","enrollment":7},{"nctId":"NCT07483684","phase":"PHASE3","title":"A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs","status":"NOT_YET_RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","startDate":"2026-03","conditions":"HER2 IHC3+ Advanced Colorectal Cancer","enrollment":142},{"nctId":"NCT05806931","phase":"PHASE2","title":"Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Rutgers, The State University of New Jersey","startDate":"2023-05-17","conditions":"Colon Cancer, Rectal Cancer","enrollment":50},{"nctId":"NCT06992258","phase":"PHASE2","title":"A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Criterium, Inc.","startDate":"2025-10-27","conditions":"Colorectal Cancer","enrollment":120},{"nctId":"NCT06607458","phase":"PHASE2","title":"Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease","status":"RECRUITING","sponsor":"Delcath Systems Inc.","startDate":"2025-08-05","conditions":"Refractory Metastatic Colorectal Cancer","enrollment":90},{"nctId":"NCT03223779","phase":"PHASE1, PHASE2","title":"Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2017-10-13","conditions":"Colorectal Cancer","enrollment":52},{"nctId":"NCT06346392","phase":"PHASE3","title":"AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2024-03-04","conditions":"Gastric Cancer, Gastroesophageal Junction Cancer","enrollment":572},{"nctId":"NCT05343013","phase":"PHASE2","title":"TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2022-06-06","conditions":"Colorectal Cancer","enrollment":25},{"nctId":"NCT03686488","phase":"PHASE2","title":"TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","status":"COMPLETED","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2018-12-20","conditions":"Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Gastric Cancer","enrollment":23},{"nctId":"NCT04511039","phase":"PHASE1","title":"Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer","status":"RECRUITING","sponsor":"Roswell Park Cancer Institute","startDate":"2021-06-08","conditions":"Advanced Malignant Solid Neoplasm, Clinical Stage III Gastroesophageal Junction Adenocarcinoma, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma","enrollment":45},{"nctId":"NCT06137170","phase":"","title":"A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment","status":"COMPLETED","sponsor":"Bayer","startDate":"2024-03-01","conditions":"Metastatic Colorectal Cancer","enrollment":121},{"nctId":"NCT05083481","phase":"PHASE1, PHASE2","title":"A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors","status":"RECRUITING","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2021-10-19","conditions":"Advanced Solid Tumors","enrollment":366},{"nctId":"NCT06356311","phase":"PHASE3","title":"A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-05-03","conditions":"Gastroesophageal Cancer","enrollment":450},{"nctId":"NCT07318389","phase":"EARLY_PHASE1","title":"ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2026-06-10","conditions":"Dynamic Tumor Resistance, Metastatic Colorectal Cancer","enrollment":100},{"nctId":"NCT07146646","phase":"PHASE2","title":"Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer","status":"RECRUITING","sponsor":"Case Comprehensive Cancer Center","startDate":"2025-12-01","conditions":"Biliary Tract Cancer, Biliary Tract Neoplasms, Cholangiocarcinoma","enrollment":27},{"nctId":"NCT05919264","phase":"PHASE1, PHASE2","title":"FOG-001 in Locally Advanced or Metastatic Solid Tumors","status":"RECRUITING","sponsor":"Parabilis Medicines, Inc.","startDate":"2023-05-23","conditions":"Cancer, Colorectal Cancer, Solid Tumor","enrollment":575},{"nctId":"NCT04109924","phase":"PHASE2","title":"TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study","status":"COMPLETED","sponsor":"Roswell Park Cancer Institute","startDate":"2019-12-27","conditions":"Advanced Colorectal Carcinoma, Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma","enrollment":42},{"nctId":"NCT05198934","phase":"PHASE3","title":"Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2022-04-19","conditions":"Colorectal Cancer (CRC)","enrollment":160},{"nctId":"NCT07270991","phase":"PHASE3","title":"Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma","status":"RECRUITING","sponsor":"Federation Francophone de Cancerologie Digestive","startDate":"2025-12-15","conditions":"Metastatic Oesogastric Adenocarcinoma","enrollment":324},{"nctId":"NCT04776148","phase":"PHASE3","title":"Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2021-03-29","conditions":"Colorectal Neoplasms","enrollment":563},{"nctId":"NCT05062889","phase":"PHASE2","title":"Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients","status":"SUSPENDED","sponsor":"Gruppo Oncologico del Nord-Ovest","startDate":"2023-05-17","conditions":"Stage II Colon Cancer, Stage III Colon Cancer, HER2-positive Colon Cancer","enrollment":477},{"nctId":"NCT07381764","phase":"PHASE2","title":"ROMANCE: \"Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer\"","status":"NOT_YET_RECRUITING","sponsor":"Gruppo Oncologico Italia Meridionale","startDate":"2026-03-30","conditions":"Metastatic Colorectal Cancer (CRC)","enrollment":150},{"nctId":"NCT04626635","phase":"PHASE1, PHASE2","title":"A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers","status":"RECRUITING","sponsor":"Regeneron Pharmaceuticals","startDate":"2020-12-21","conditions":"Advanced Solid Tumors","enrollment":933},{"nctId":"NCT07371871","phase":"NA","title":"A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer","status":"NOT_YET_RECRUITING","sponsor":"Anhui Provincial Cancer Hospital","startDate":"2026-01-08","conditions":"Advanced Gastric Cancer","enrollment":30},{"nctId":"NCT07361003","phase":"PHASE3","title":"A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Jiangsu Simcere Pharmaceutical Co., Ltd.","startDate":"2025-11-12","conditions":"Refractory Metastatic Colorectal Cancer","enrollment":464},{"nctId":"NCT07286695","phase":"PHASE2","title":"Fruquintinib Combined With Trifluridine/Tipiracil Versus Bevacizumab Combined With Trifluridine/Tipiracil for Advanced Metastatic Colorectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","startDate":"2025-12-31","conditions":"Metastatic Colorectal Cancer (CRC), Colorectal Cancer","enrollment":292},{"nctId":"NCT04457297","phase":"PHASE3","title":"Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection","status":"COMPLETED","sponsor":"National Cancer Center Hospital East","startDate":"2020-07-08","conditions":"Colorectal Neoplasms, Trifluridine and Tipiracil, Circulating Tumor DNA","enrollment":243},{"nctId":"NCT07353268","phase":"PHASE2","title":"Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerability, and Efficacy.","status":"NOT_YET_RECRUITING","sponsor":"Tao Zhang","startDate":"2026-01-21","conditions":"Colorectal Cancer","enrollment":76},{"nctId":"NCT03844620","phase":"PHASE2","title":"Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2019-01-29","conditions":"Refractory Colorectal Carcinoma, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8","enrollment":100},{"nctId":"NCT04564898","phase":"PHASE1, PHASE2","title":"Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Gruppo Oncologico del Nord-Ovest","startDate":"2022-01-25","conditions":"Colorectal Cancer Metastatic","enrollment":48},{"nctId":"NCT05405595","phase":"PHASE1, PHASE2","title":"ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors","status":"RECRUITING","sponsor":"Adagene Inc","startDate":"2022-06-15","conditions":"Advanced/Metastatic Solid Tumors","enrollment":186},{"nctId":"NCT06680622","phase":"PHASE2","title":"Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","startDate":"2025-03-03","conditions":"Metastatic Gastro-esophageal Adenocarcinoma","enrollment":126},{"nctId":"NCT03869892","phase":"PHASE3","title":"Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Institut de Recherches Internationales Servier","startDate":"2019-03-21","conditions":"Metastatic Colorectal Cancer","enrollment":856},{"nctId":"NCT07280377","phase":"PHASE1, PHASE2","title":"A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab","status":"RECRUITING","sponsor":"Oncolytics Biotech","startDate":"2021-10-27","conditions":"Anal Cancer Metastatic, Squamous Cell Carcinoma of the Anus Stage Unspecified, Pancreatic Cancer Metastatic","enrollment":122},{"nctId":"NCT06856837","phase":"PHASE2","title":"- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases","status":"RECRUITING","sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","startDate":"2025-10-27","conditions":"Metastatic Colorectal Cancer","enrollment":140},{"nctId":"NCT04417699","phase":"PHASE2","title":"SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer","status":"COMPLETED","sponsor":"Providence Health & Services","startDate":"2022-07-05","conditions":"Rectal Cancer","enrollment":13},{"nctId":"NCT06245356","phase":"PHASE2","title":"Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer","status":"RECRUITING","sponsor":"UNICANCER","startDate":"2025-03-21","conditions":"Metastatic Colorectal Cancer, Metastatic Gastroesophageal Adenocarcinoma, DPD Deficiency","enrollment":73},{"nctId":"NCT07261709","phase":"PHASE2","title":"Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2025-12-01","conditions":"Refractory Metastatic Colorectal Cancer","enrollment":236},{"nctId":"NCT05600309","phase":"PHASE3","title":"A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2022-06-14","conditions":"Colorectal Cancer","enrollment":94},{"nctId":"NCT05438459","phase":"PHASE1, PHASE2","title":"GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites","status":"RECRUITING","sponsor":"Kyushu University","startDate":"2022-06-08","conditions":"Gastric Cancer, Pancreatic Cancer","enrollment":130},{"nctId":"NCT05839951","phase":"","title":"An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions","status":"COMPLETED","sponsor":"Bayer","startDate":"2023-04-24","conditions":"Metastatic Colorectal Cancer (mCRC)","enrollment":818},{"nctId":"NCT04042714","phase":"PHASE2","title":"TAS-102 in Extrapulmonary Neuroendocrine Carcinoma","status":"TERMINATED","sponsor":"Baylor Research Institute","startDate":"2019-08-15","conditions":"High-grade Extra Pulmonary Neuroendocrine Cancer","enrollment":14},{"nctId":"NCT05029882","phase":"PHASE1","title":"Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab","status":"ACTIVE_NOT_RECRUITING","sponsor":"AbbVie","startDate":"2021-10-13","conditions":"Non-Small Cell Lung Cancer, Advanced Solid Tumors, Gastroesophageal Adenocarcinoma","enrollment":520},{"nctId":"NCT04104139","phase":"PHASE1","title":"TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"OHSU Knight Cancer Institute","startDate":"2019-12-11","conditions":"Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8","enrollment":19},{"nctId":"NCT07212933","phase":"PHASE2","title":"The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial","status":"RECRUITING","sponsor":"Chinese PLA General Hospital","startDate":"2025-07-01","conditions":"Gastric (Stomach) Cancer, Biological Therapy, Immunotherapy","enrollment":90},{"nctId":"NCT06699836","phase":"PHASE2","title":"A Phase 2 Study of Leronlimab in Combination With TAS-102 + Bevacizumab in Previously Treated Participants With mCRC","status":"RECRUITING","sponsor":"CytoDyn, Inc.","startDate":"2025-06-16","conditions":"Metastatic Colorectal Cancer (mCRC)","enrollment":60},{"nctId":"NCT07196345","phase":"PHASE1, PHASE2","title":"TAS-102 Plus Radiotherapy in Elderly ESCC","status":"NOT_YET_RECRUITING","sponsor":"Qianfoshan Hospital","startDate":"2025-09-25","conditions":"ESCC, TAS 102, Radiotherapy","enrollment":45},{"nctId":"NCT04280536","phase":"PHASE1, PHASE2","title":"Phase II Study of FTD/TPI (Lonsurf) in Metastatic Breast Cancers With or Without Prior Exposure to Fluoropyrimidines (LONBRECA)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National University Hospital, Singapore","startDate":"2019-08-14","conditions":"Breast Cancer","enrollment":86},{"nctId":"NCT04489173","phase":"PHASE2","title":"TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Borstkanker Onderzoek Groep","startDate":"2020-09-25","conditions":"Breast Neoplasm, Chemotherapy Effect","enrollment":52},{"nctId":"NCT05064059","phase":"PHASE3","title":"A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2021-11-10","conditions":"Colorectal Cancer","enrollment":441},{"nctId":"NCT07171554","phase":"NA","title":"Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"Oncosyne AS","startDate":"2025-09","conditions":"Metastatic Colorectal Cancer (mCRC)","enrollment":75},{"nctId":"NCT05608044","phase":"PHASE2","title":"A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Agenus Inc.","startDate":"2022-11-30","conditions":"Metastatic Colorectal Cancer","enrollment":234},{"nctId":"NCT06887218","phase":"PHASE2","title":"5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"The Methodist Hospital Research Institute","startDate":"2025-05-08","conditions":"Metastatic Colorectal Cancer (CRC)","enrollment":57},{"nctId":"NCT06614192","phase":"PHASE3","title":"A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"AbbVie","startDate":"2024-11-08","conditions":"Metastatic Colorectal Cancer","enrollment":460},{"nctId":"NCT07142421","phase":"PHASE2","title":"A Study of Trifluridine/Tipiracil Combined With Anlotinib as Second-line Treatment for Recurrent and Metastatic Esophageal Squamous Cell Carcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2025-08-06","conditions":"Esophageal Squamous Cell Carcinoma (ESCC)","enrollment":35},{"nctId":"NCT06764680","phase":"PHASE2","title":"Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2024-12-31","conditions":"Colorectal Cancer Metastatic, Chemotherapy, Targeted Therapy","enrollment":57},{"nctId":"NCT06238843","phase":"PHASE3","title":"A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma","status":"RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2024-06-30","conditions":"Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","enrollment":450},{"nctId":"NCT07138885","phase":"PHASE2","title":"A Phase II, Single-Arm, Prospective Trial on the Efficacy and Safety of QL1706 Combination Regimen as Second-Line Therapy for Targeted-Immunotherapy-Resistant Hepatocellular Carcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2025-08-01","conditions":"Hepatocellular Carcinoma (HCC), Second Line Treatment","enrollment":62},{"nctId":"NCT05927857","phase":"PHASE1, PHASE2","title":"Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .","status":"RECRUITING","sponsor":"National Health Research Institutes, Taiwan","startDate":"2024-04-01","conditions":"Metastatic Gastric Adenocarcinoma, Second Line, Chemotherapy","enrollment":45},{"nctId":"NCT04166604","phase":"PHASE2","title":"LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy","status":"ACTIVE_NOT_RECRUITING","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","startDate":"2020-05-20","conditions":"Metastatic Colorectal Cancer","enrollment":176},{"nctId":"NCT05328908","phase":"PHASE3","title":"A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer","status":"TERMINATED","sponsor":"Bristol-Myers Squibb","startDate":"2022-04-28","conditions":"Colorectal Neoplasms","enrollment":770},{"nctId":"NCT07116577","phase":"PHASE2","title":"Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC","status":"NOT_YET_RECRUITING","sponsor":"Jinan Central Hospital","startDate":"2025-08-31","conditions":"mCRC","enrollment":37},{"nctId":"NCT07090031","phase":"PHASE2","title":"Perioperative Treatment With TAS-102 in Combination With Oxaliplatin for Locally Advanced Rectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Qingdao Central Hospital","startDate":"2025-07-01","conditions":"EFS, pCR Rate","enrollment":49},{"nctId":"NCT07085169","phase":"PHASE2","title":"Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC","status":"RECRUITING","sponsor":"Ruijin Hospital","startDate":"2025-08-01","conditions":"Colo-rectal Cancer, Third-line and Beyond Therapy, TAS 102","enrollment":50},{"nctId":"NCT04923529","phase":"PHASE2","title":"TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma","status":"COMPLETED","sponsor":"The University of Hong Kong","startDate":"2021-03-01","conditions":"Pancreas Cancer","enrollment":28},{"nctId":"NCT06199973","phase":"PHASE3","title":"Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan","status":"ACTIVE_NOT_RECRUITING","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","startDate":"2024-03-01","conditions":"Advanced Colorectal Cancer","enrollment":130},{"nctId":"NCT04879368","phase":"PHASE3","title":"RegoNivo vs Standard of Care Chemotherapy in AGOC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Australasian Gastro-Intestinal Trials Group","startDate":"2021-06-01","conditions":"Gastro-Oesophageal Cancer","enrollment":450},{"nctId":"NCT07071844","phase":"PHASE2","title":"BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients","status":"NOT_YET_RECRUITING","sponsor":"GERCOR - Multidisciplinary Oncology Cooperative Group","startDate":"2025-09","conditions":"Metastatic Colorectal Cancer","enrollment":162},{"nctId":"NCT06873763","phase":"PHASE1, PHASE2","title":"Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer","status":"RECRUITING","sponsor":"STCube, Inc.","startDate":"2025-06-09","conditions":"Metastatic Colorectal Cancer (CRC), Recurrent Colorectal Cancer","enrollment":52},{"nctId":"NCT05508737","phase":"PHASE1, PHASE2","title":"Pembrolizumab and Trifluridine/Tipiracil With Previously Treated Advanced Gastric Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yonsei University","startDate":"2022-12-01","conditions":"Gastric and Gastroesophageal Junction Adenocarcinoma","enrollment":75},{"nctId":"NCT06850090","phase":"PHASE3","title":"Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial","status":"NOT_YET_RECRUITING","sponsor":"Shandong Cancer Hospital and Institute","startDate":"2025-07-30","conditions":"Rectal Cancer, Rectal Cancer Patients","enrollment":210},{"nctId":"NCT07012954","phase":"PHASE1, PHASE2","title":"ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2025-06-01","conditions":"Colorectal Cancer Metastatic","enrollment":64},{"nctId":"NCT05854498","phase":"PHASE2","title":"Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Wisconsin, Madison","startDate":"2023-10-13","conditions":"Metastatic Colorectal Cancer","enrollment":25},{"nctId":"NCT05201352","phase":"PHASE1, PHASE2","title":"Evaluation of Efficacy of Trifluridine/Tipiracil Plus an Anti-IL-1α True Human Antibody Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine","status":"ACTIVE_NOT_RECRUITING","sponsor":"Centre Georges Francois Leclerc","startDate":"2022-10-13","conditions":"Metastatic Colorectal Cancer","enrollment":160},{"nctId":"NCT04393298","phase":"PHASE1, PHASE2","title":"A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors","status":"COMPLETED","sponsor":"UCB Biopharma SRL","startDate":"2020-07-09","conditions":"Advanced Solid Tumors","enrollment":93},{"nctId":"NCT06992648","phase":"PHASE3","title":"Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-04-01","conditions":"Colorectal Cancer Metastatic, Colorectal Cancer Recurrent","enrollment":302},{"nctId":"NCT05481463","phase":"PHASE2","title":"Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2023-01-30","conditions":"Pancreatic Neoplasms","enrollment":22},{"nctId":"NCT05312398","phase":"PHASE2","title":"CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2021-07-15","conditions":"Metastatic Colorectal Adenocarcinoma","enrollment":219},{"nctId":"NCT05848739","phase":"PHASE1","title":"A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors","status":"RECRUITING","sponsor":"Sapience Therapeutics","startDate":"2023-06-05","conditions":"Colon Cancer, Metastatic Colon Cancer","enrollment":130},{"nctId":"NCT04097028","phase":"PHASE2","title":"Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma","status":"COMPLETED","sponsor":"Roswell Park Cancer Institute","startDate":"2019-12-20","conditions":"Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8","enrollment":22},{"nctId":"NCT05965531","phase":"PHASE2","title":"Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2024-01-01","conditions":"Rectal Cancer","enrollment":65},{"nctId":"NCT04868773","phase":"PHASE1","title":"Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of California, Irvine","startDate":"2021-07-16","conditions":"Colorectal Cancer, Colorectal Carcinoma, Metastatic Cancer","enrollment":12},{"nctId":"NCT04920032","phase":"PHASE1","title":"Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas","status":"RECRUITING","sponsor":"University of California, Irvine","startDate":"2021-08-26","conditions":"Colon Adenocarcinoma, Colorectal Cancer","enrollment":22},{"nctId":"NCT04450836","phase":"PHASE2","title":"Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer","status":"TERMINATED","sponsor":"UNICANCER","startDate":"2020-11-23","conditions":"Metastatic Colorectal Cancer","enrollment":234},{"nctId":"NCT06882915","phase":"PHASE1","title":"Efficacy and Safety of Trifluridine/tipiracil (TAS-102) Combined with Bevacizumab and Putalimab in the Treatment of Patients with MCRC After Cytoreductive Surgery: a Single-arm, Single-center Clinical Study","status":"NOT_YET_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-05-01","conditions":"Colorectal Cancer (CRC)","enrollment":20},{"nctId":"NCT06872606","phase":"PHASE2","title":"Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"Sir Run Run Shaw Hospital","startDate":"2025-04-01","conditions":"Rectal Adenocarcinoma","enrollment":33},{"nctId":"NCT06522919","phase":"PHASE2","title":"Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","startDate":"2025-01-07","conditions":"Colorectal Cancer Metastatic, Microsatellite Stable Colorectal Carcinoma, Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer","enrollment":36},{"nctId":"NCT03368963","phase":"PHASE1, PHASE2","title":"TAS102 in Combination With NAL-IRI in Advanced GI Cancers","status":"ACTIVE_NOT_RECRUITING","sponsor":"Emory University","startDate":"2018-01-30","conditions":"Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma","enrollment":64},{"nctId":"NCT04260269","phase":"","title":"Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity Study","status":"ENROLLING_BY_INVITATION","sponsor":"Helsinki University Central Hospital","startDate":"2018-06-01","conditions":"Solid Tumor","enrollment":200},{"nctId":"NCT03665506","phase":"","title":"Trifluridin/tipirACil in MeTastatIc Colorectal Cancer","status":"COMPLETED","sponsor":"Servier","startDate":"2018-06-25","conditions":"Metastatic Colorectal Cancer","enrollment":315},{"nctId":"NCT06711471","phase":"PHASE2","title":"Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As Third-line or Later-line Therapy of Gastric Cancer","status":"RECRUITING","sponsor":"LIN YANG","startDate":"2024-11-14","conditions":"Gastric Cancer Adenocarcinoma Metastatic","enrollment":31},{"nctId":"NCT04701476","phase":"PHASE2","title":"TATE and Pembrolizumab (MK3475) in mCRC and NSCLC","status":"RECRUITING","sponsor":"Teclison Ltd.","startDate":"2021-05-20","conditions":"Colorectal Cancer; Lung Cancer","enrollment":110},{"nctId":"NCT04294264","phase":"PHASE2","title":"TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Rutgers, The State University of New Jersey","startDate":"2019-02-12","conditions":"Metastatic Colorectal Carcinoma, Recurrent Colon Carcinoma, Refractory Colorectal Carcinoma","enrollment":50},{"nctId":"NCT02261532","phase":"PHASE1","title":"A Phase I Study of TAS-102 in Solid Tumors","status":"COMPLETED","sponsor":"Taiho Pharmaceutical Co., Ltd.","startDate":"2014-09","conditions":"Advanced or Metastatic Solid Tumors","enrollment":15},{"nctId":"NCT05476796","phase":"PHASE2","title":"Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer","status":"RECRUITING","sponsor":"UNICANCER","startDate":"2023-06-23","conditions":"Gastric Adenocarcinoma, Esophagus Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma","enrollment":118},{"nctId":"NCT03251378","phase":"PHASE1","title":"A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers","status":"COMPLETED","sponsor":"Hutchison Medipharma Limited","startDate":"2017-12-11","conditions":"Advanced Solid Tumors, Metastatic Colon Cancer, Metastatic Breast Cancer","enrollment":129},{"nctId":"NCT04999761","phase":"PHASE1","title":"AB122 Platform Study","status":"RECRUITING","sponsor":"Taiho Pharmaceutical Co., Ltd.","startDate":"2021-06-01","conditions":"Advanced or Metastatic Solid Tumor, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer","enrollment":917},{"nctId":"NCT04737187","phase":"PHASE3","title":"Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients","status":"COMPLETED","sponsor":"Taiho Oncology, Inc.","startDate":"2020-11-25","conditions":"Refractory Metastatic Colorectal Cancer","enrollment":492}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Trifluridine-tipiracil","genericName":"Trifluridine-tipiracil","companyName":"The Methodist Hospital Research Institute","companyId":"the-methodist-hospital-research-institute","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Trifluridine-tipiracil is a thymidine kinase 1 inhibitor that also has a thymidylate synthase inhibitor component, which works by interfering with DNA synthesis in cancer cells. Used for Metastatic colorectal cancer.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}