# Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer

Source: https://onco.cc/trials/nct07831993/  
OnCo record `nct07831993` (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, cisplatin and other drugs in gallbladder cancer and other biliary tract cancers, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, now recruiting.

## Summary

Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer is a phase 2, randomised interventional study registered as NCT07831993 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with a registry enrolment figure of 54 participants, started 2026-01-14 and due to reach its primary completion in 2027-06-30. Interventions recorded: Sintilimab, Irinotecan Hydrochloride Liposome Injection (II), Oxaliplatin, Leucovorin, Fluorouracil, gemcitabine, Cisplatin. 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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; gallbladder-deep-dive
- Registry id: NCT07831993
- Phase: 2
- Setting: A Randomized, Noncomparative, Open-Label, Exploratory Clinical Study of Sintilimab in Combination With NALIRIFOX (Liposomal Irinotecan [II] Plus 5-Fluorouracil/Leucovorin and Oxaliplatin) or GP (Gemcitabine Plus Cisplatin) as First-Line Treatment for Metastatic Biliary Tract Cancer
- Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Enrolled: 54

## Sources

- ClinicalTrials.gov NCT07831993: https://clinicaltrials.gov/study/NCT07831993

## 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/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Irinotecan (and liposomal irinotecan)](https://onco.cc/drugs/irinotecan/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/), [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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