{"entity":{"id":"nct07797816","kind":"trial","name":"Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer","aka":[],"tldr":"A phase 2 trial of sintilimab, fluorouracil, leucovorin and liposomal irinotecan with radiotherapy in gallbladder cancer and other biliary tract cancers, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, now recruiting.","summary":"Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer is a phase 2 interventional study registered as NCT07797816 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 31 participants, started 2026-01-08 and due to reach its primary completion in 2028-12-31. Interventions recorded: Irinotecan Hydrochloride Liposome Injection (II), Fluorouracil, Leucovorin, Sintilimab, Stereotactic Body Radiation Therapy, Radical Surgical Resection. Conditions listed: Biliary Tract Cancer. Gallbladder cancer is named in the registry entry: \"2. Histologically and/or cytologically confirmed biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\". Sites: China. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07797816","url":"https://clinicaltrials.gov/study/NCT07797816"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","sbrt"],"targets":[],"drugs":["sintilimab","fluorouracil","leucovorin","liposomal-irinotecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07797816","phase":"2","setting":"A Prospective, Single-Arm, Exploratory Clinical Study of Liposomal Irinotecan (II) Plus 5-Fluorouracil/Leucovorin and Sintilimab With Sequential Stereotactic Body Radiation Therapy as First-Line Treatment for Locally Advanced Biliary Tract Cancer","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","enrolled":31,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07797816/","neighbours":{"cancer":[{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"extrahepatic-cholangiocarcinoma","kind":"cancer","name":"Extrahepatic cholangiocarcinoma (perihilar and distal)","route":"/cancers/extrahepatic-cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"sbrt","kind":"technology","name":"SBRT / SABR (stereotactic radiotherapy)","route":"/technologies/sbrt/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"liposomal-irinotecan","kind":"drug","name":"Liposomal irinotecan","route":"/drugs/liposomal-irinotecan/"},{"id":"sintilimab","kind":"drug","name":"Sintilimab","route":"/drugs/sintilimab/"}],"term":[{"id":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"}]}}