{"id":"irinotecan-tegafur","safety":{"commonSideEffects":[{"rate":null,"effect":"Neutropenia"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea/vomiting"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Mucositis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This combination leverages two complementary chemotherapy mechanisms: irinotecan causes DNA damage by stabilizing topoisomerase I-DNA complexes, leading to double-strand breaks during replication, while tegafur (a 5-FU prodrug) blocks thymidylate synthase to deplete dTMP and inhibit DNA synthesis. The dual mechanism targets cancer cells through both direct DNA damage and nucleotide depletion pathways.","oneSentence":"Irinotecan inhibits topoisomerase I to prevent DNA unwinding during replication, while tegafur is a prodrug of fluorouracil that inhibits thymidylate synthase to disrupt nucleotide synthesis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:14.174Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Colorectal cancer (phase 3 development)"},{"name":"Gastric cancer (potential indication)"}]},"trialDetails":[{"nctId":"NCT07472868","phase":"PHASE3","title":"Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer","status":"NOT_YET_RECRUITING","sponsor":"J. W. A. Burger","startDate":"2026-03-03","conditions":"Locally Advanced Rectal Carcinoma","enrollment":394},{"nctId":"NCT07262567","phase":"PHASE3","title":"Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer","status":"NOT_YET_RECRUITING","sponsor":"Genfleet Therapeutics (Shanghai) Inc.","startDate":"2025-12","conditions":"Metastatic Pancreatic Cancer","enrollment":320},{"nctId":"NCT04415853","phase":"PHASE3","title":"Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer","status":"RECRUITING","sponsor":"Sunshine Lake Pharma Co., Ltd.","startDate":"2021-01-21","conditions":"Esophageal Cancer","enrollment":416},{"nctId":"NCT06383078","phase":"PHASE2","title":"HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2024-04-20","conditions":"Efficacy and Safety","enrollment":120},{"nctId":"NCT06361316","phase":"NA","title":"Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer","status":"RECRUITING","sponsor":"Kuirong Jiang","startDate":"2024-04-08","conditions":"Pancreatic Cancer, Adjuvant Therapy","enrollment":53},{"nctId":"NCT06194734","phase":"PHASE3","title":"A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer","status":"RECRUITING","sponsor":"Beijing Konruns Pharmaceutical Co., Ltd.","startDate":"2024-02-05","conditions":"Esophageal Squamous Cell Carcinoma","enrollment":490},{"nctId":"NCT03811652","phase":"PHASE1","title":"A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2018-12-20","conditions":"Non Small Cell Lung Cancer Squamous (NSCLC-Sq), Head and Neck Squamous Cell Carcinoma (HNSCC), Small Cell Lung Cancer (SCLC)","enrollment":8},{"nctId":"NCT03316326","phase":"PHASE2","title":"S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2017-11-01","conditions":"Pancreatic Ductal Adenocarcinoma","enrollment":35},{"nctId":"NCT02527785","phase":"PHASE2","title":"Study of Oxaliplatin, Irinotecan, and S-1 in Gastric Cancer","status":"COMPLETED","sponsor":"Hallym University Medical Center","startDate":"2015-02","conditions":"Stomach Neoplasm","enrollment":44},{"nctId":"NCT02527824","phase":"PHASE2","title":"Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer","status":"UNKNOWN","sponsor":"Hallym University Medical Center","startDate":"2015-03","conditions":"Biliary Tract Neoplasm","enrollment":31},{"nctId":"NCT01225744","phase":"PHASE2","title":"Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy","status":"COMPLETED","sponsor":"The Christie NHS Foundation Trust","startDate":"2009-04","conditions":"Metastatic Colorectal Cancer","enrollment":47},{"nctId":"NCT00134095","phase":"PHASE2","title":"S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer","status":"UNKNOWN","sponsor":"Fukushima Medical University Hospital","startDate":"2004-09","conditions":"Gastric Cancer","enrollment":70},{"nctId":"NCT00974389","phase":"PHASE2","title":"S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery","status":"UNKNOWN","sponsor":"Osaka Medical College","startDate":"2009-07","conditions":"Colorectal Cancer","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":167,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Irinotecan Hydrochloride Injection/Tegafur Gimeracil Oteracil Potassium Capsule"],"phase":"phase_3","status":"active","brandName":"Irinotecan/Tegafur","genericName":"Irinotecan/Tegafur","companyName":"Sunshine Lake Pharma Co., Ltd.","companyId":"sunshine-lake-pharma-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Irinotecan is a small molecule inhibitor of DNA topoisomerase 1, classified as an INHIBITOR. It is being studied in clinical trials for various types of cancer, including Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, and Colorectal Cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}