{"entity":{"id":"nct07654530","kind":"trial","name":"Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC.","aka":["SIAG-BTC"],"tldr":"A phase 2 trial of ipilimumab, sintilimab, gemcitabine and nab-paclitaxel in gallbladder cancer and other biliary tract cancers, run by Tianjin Medical University Cancer Institute and Hospital, active and no longer recruiting.","summary":"Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC. is a phase 2, randomised interventional study registered as NCT07654530 by Tianjin Medical University Cancer Institute and Hospital, with a registry enrolment figure of 107 participants, started 2026-04-24 and due to reach its primary completion in 2028-06-30. Interventions recorded: Sintilimab + Ipilimumab (N01) + AG, Sintilimab Combined with Albumin-bound Paclitaxel and Gemcitabine (AG). Conditions listed: Biliary Tract Cancers (BTC). Gallbladder cancer is named in the registry entry: \"* Histologically or cytologically confirmed locally advanced or metastatic biliary tract malignancies, including intrahepatic cholangiocarcinoma (iCCA), extrahepatic cholangiocarcinoma (eCCA) and gallbladder carcinoma (G\". Sites: China. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07654530","url":"https://clinicaltrials.gov/study/NCT07654530"}],"tags":["ctgov-ingest","gallbladder-deep-dive"],"related":[],"cancers":["gallbladder","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["ipilimumab","sintilimab","gemcitabine","nab-paclitaxel"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07654530","phase":"2","setting":"Sintilimab Combined With Ipilimumab (N01) Plus Albumin-bound Paclitaxel and Gemcitabine (AG) as First-line Therapy for Unresectable Locally Advanced or Metastatic Biliary Tract Malignancies: A Prospective Phase II Clinical Study.","sponsor":"Tianjin Medical University Cancer Institute and Hospital","enrolled":107,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07654530/","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/"}],"drug":[{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nab-paclitaxel","kind":"drug","name":"Nab-paclitaxel","route":"/drugs/nab-paclitaxel/"},{"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/"}]}}