# The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors

Source: https://onco.cc/trials/nct07109167/  
OnCo record `nct07109167` (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 benmelstobart, gemcitabine and cisplatin in gallbladder cancer and other biliary tract cancers, run by The Second Affiliated Hospital of Shandong First Medical University, not yet recruiting.

## Summary

The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors is a phase 2 interventional study registered as NCT07109167 by The Second Affiliated Hospital of Shandong First Medical University, with a registry enrolment figure of 30 participants, started 2025-08-01 and due to reach its primary completion in 2026-08-01. Interventions recorded: Benmelstobart combined with gemcitabine and cisplatin. Conditions listed: Biliary Tract Neoplasms. Gallbladder cancer is named in the registry entry: "Age: 18 to 75 years old, inclusive; of either sex. Histopathologically confirmed unresectable and previously untreated gallbladder cancer or intrahepatic/extrahepatic cholangiocarcinoma, with at least one measurable lesi". 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: NCT07109167
- Phase: 2
- Setting: The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors
- Sponsor: The Second Affiliated Hospital of Shandong First Medical University
- Enrolled: 30

## Sources

- ClinicalTrials.gov NCT07109167: https://clinicaltrials.gov/study/NCT07109167

## 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: [Benmelstobart](https://onco.cc/drugs/benmelstobart/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)

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