# Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer

Source: https://onco.cc/trials/nct07638501/  
OnCo record `nct07638501` (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 sintilimab, gemcitabine and cisplatin with radiotherapy in gallbladder cancer and other biliary tract cancers, run by Eastern Hepatobiliary Surgery Hospital, not yet recruiting.

## Summary

Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT07638501 by Eastern Hepatobiliary Surgery Hospital, with a registry enrolment figure of 123 participants, started 2026-06-15 and due to reach its primary completion in 2028-06-15. Interventions recorded: Sintilimab + GC, SBRT 7Gy✖️5 QD. Conditions listed: Biliary Tract Cancer (BTC). Gallbladder cancer is named in the registry entry: "3. Histologically or cytologically confirmed, unresectable advanced or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.". Sites: China. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; gallbladder-deep-dive
- Registry id: NCT07638501
- Phase: 2
- Setting: Evaluation of the Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) Combined With Gemcitabine, Cisplatin, and Sintilimab as First-Line Therapy for Unresectable Biliary Tract Cancer: A Prospective, Multicenter, Randomized Controlled Study
- Sponsor: Eastern Hepatobiliary Surgery Hospital
- Enrolled: 123

## Sources

- ClinicalTrials.gov NCT07638501: https://clinicaltrials.gov/study/NCT07638501

## 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/), [Platinum agents](https://onco.cc/technologies/platinum/), [SBRT / SABR (stereotactic radiotherapy)](https://onco.cc/technologies/sbrt/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [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/), [Radiotherapy](https://onco.cc/terms/radiotherapy/)

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