{"id":"lenvatinib-sintilimab-plus-tace","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Proteinuria"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Immune-related adverse events (from sintilimab)"},{"rate":null,"effect":"Post-embolization syndrome (from TACE)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Lenvatinib inhibits multiple receptor tyrosine kinases (FGFR, VEGFR, RET, KIT) to suppress tumor angiogenesis and growth. Sintilimab is a PD-1 checkpoint inhibitor that restores anti-tumor T-cell immunity. TACE delivers chemotherapy directly to the tumor while occluding its blood supply. The combination aims to synergize anti-angiogenic, immunologic, and locoregional cytotoxic effects in advanced hepatocellular carcinoma.","oneSentence":"This combination uses lenvatinib (a multi-kinase inhibitor) and sintilimab (a PD-1 inhibitor) together with TACE (transarterial chemoembolization) to target hepatocellular carcinoma through anti-angiogenic, immunostimulatory, and locoregional chemotherapy mechanisms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:40.622Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or unresectable hepatocellular carcinoma"}]},"trialDetails":[{"nctId":"NCT07487662","phase":"PHASE2","title":"TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2026-03-18","conditions":"Hepato Cellular Carcinoma (HCC)","enrollment":105},{"nctId":"NCT07157969","phase":"PHASE2","title":"ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC","status":"RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2025-02-19","conditions":"HCC - Hepatocellular Carcinoma","enrollment":300},{"nctId":"NCT06740370","phase":"NA","title":"TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2024-12-13","conditions":"Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Anti-PD1 Antibody","enrollment":32},{"nctId":"NCT06904183","phase":"PHASE2","title":"Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT","status":"RECRUITING","sponsor":"Second Affiliated Hospital of Guangzhou Medical University","startDate":"2025-04-01","conditions":"Hepatocellular Carcinoma Non-resectable","enrollment":320},{"nctId":"NCT06643533","phase":"","title":"Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)","status":"NOT_YET_RECRUITING","sponsor":"Fujian Provincial Hospital","startDate":"2025-01-01","conditions":"Hepatocellular Carcinoma Non-resectable","enrollment":15},{"nctId":"NCT06561399","phase":"","title":"Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)","status":"RECRUITING","sponsor":"Fujian Provincial Hospital","startDate":"2024-08-15","conditions":"Hepatocellular Carcinoma Non-resectable","enrollment":28},{"nctId":"NCT05717738","phase":"","title":"Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma","status":"RECRUITING","sponsor":"Tongji Hospital","startDate":"2022-01-20","conditions":"Hepatocellular Carcinoma Non-resectable","enrollment":300},{"nctId":"NCT06261138","phase":"","title":"Survival Analysis: TACE vs. Combination Therapy in HCC","status":"COMPLETED","sponsor":"Zhejiang University","startDate":"2019-02-01","conditions":"Hepatocellular Carcinoma","enrollment":279},{"nctId":"NCT06205732","phase":"","title":"A Retrospective Study on the Treatment of Intermediate and Advanced Liver Cancer.","status":"UNKNOWN","sponsor":"Qianfoshan Hospital","startDate":"2024-01-01","conditions":"Carcinoma, Hepatocellular","enrollment":100},{"nctId":"NCT06194695","phase":"","title":"DEB-TACE, Lenvatinib and Anti-PD(L)1 Antibody as Conversion Therapy for Intrahepatic Cholangiocarcinoma","status":"UNKNOWN","sponsor":"Ze-yang Ding, MD","startDate":"2022-02-01","conditions":"Cholangiocarcinoma Non-resectable","enrollment":100},{"nctId":"NCT06089382","phase":"PHASE3","title":"A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection","status":"NOT_YET_RECRUITING","sponsor":"Tongji Hospital","startDate":"2023-11-01","conditions":"Hepatocellular Carcinoma","enrollment":104},{"nctId":"NCT05250843","phase":"PHASE2, PHASE3","title":"TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC","status":"UNKNOWN","sponsor":"Third Affiliated Hospital, Sun Yat-Sen University","startDate":"2022-05-30","conditions":"Hepatocellular Carcinoma","enrollment":90},{"nctId":"NCT05985798","phase":"PHASE3","title":"Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC","status":"RECRUITING","sponsor":"Second Affiliated Hospital of Guangzhou Medical University","startDate":"2023-08-01","conditions":"Hepatocellular Carcinoma Non-resectable","enrollment":258},{"nctId":"NCT05608200","phase":"PHASE3","title":"Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC","status":"RECRUITING","sponsor":"Second Affiliated Hospital of Guangzhou Medical University","startDate":"2022-11-02","conditions":"Hepatocellular Carcinoma Non-resectable","enrollment":427},{"nctId":"NCT05332496","phase":"","title":"TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Intermediate HCC","status":"UNKNOWN","sponsor":"Zhongda Hospital","startDate":"2022-12-28","conditions":"Hepatocellular Carcinoma","enrollment":220},{"nctId":"NCT05332821","phase":"","title":"TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Advanced HCC","status":"UNKNOWN","sponsor":"Zhongda Hospital","startDate":"2022-12-28","conditions":"Hepatocellular Carcinoma","enrollment":474},{"nctId":"NCT04599790","phase":"PHASE2","title":"TACE Combined With Lenvatinib and Sintilimab for Advanced HCC","status":"COMPLETED","sponsor":"Second Affiliated Hospital of Guangzhou Medical University","startDate":"2020-10-01","conditions":"Hepatocellular Carcinoma Non-resectable","enrollment":30},{"nctId":"NCT05535998","phase":"","title":"TACE-HAIC Combined With TKIs and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With PVTT","status":"COMPLETED","sponsor":"Yunfei Yuan","startDate":"2021-01-01","conditions":"Hepatocellular Carcinoma","enrollment":743},{"nctId":"NCT05247996","phase":"NA","title":"TACE Combined With \"Target Immune\" Therapy for First-line Treatment in the Treatment of Intrahepatic Cholangiocarcinoma","status":"UNKNOWN","sponsor":"The Central Hospital of Lishui City","startDate":"2022-03-01","conditions":"Intrahepatic Cholangiocarcinoma","enrollment":98},{"nctId":"NCT04814043","phase":"PHASE2","title":"PD-1 Antibody and Lenvatinib Plus TACE-HAIC for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2021-04-20","conditions":"Hepatocellular Carcinoma","enrollment":57}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"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":"Lenvatinib, sintilimab plus TACE","genericName":"Lenvatinib, sintilimab plus TACE","companyName":"Second Affiliated Hospital of Guangzhou Medical University","companyId":"second-affiliated-hospital-of-guangzhou-medical-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination uses lenvatinib (a multi-kinase inhibitor) and sintilimab (a PD-1 inhibitor) together with TACE (transarterial chemoembolization) to target hepatocellular carcinoma through anti-angiogenic, immunostimulatory, and locoregional chemotherapy mechanisms. Used for Advanced or unresectable hepatocellular carcinoma.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}