# Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC.

Source: https://onco.cc/trials/nct07654530/  
OnCo record `nct07654530` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: SIAG-BTC
- Tags: ctgov-ingest; gallbladder-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT07654530: https://clinicaltrials.gov/study/NCT07654530

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/), [Sintilimab](https://onco.cc/drugs/sintilimab/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)

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