drugset / Trial / NCT05924880

A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)

NCT05924880

Phase 3 Completed 116 enrolled AstraZeneca
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase IIIb, open-label, single arm, multicentre study to assess the safety and efficacy of durvalumab in combination with investigator's choice of 3 different gemcitabine-based chemotherapy regimens in participants with aBTC with a WHO/ECOG PS of 0 to 2 at enrolment.

Timeline

Start
2023-07-21
Primary completion
2025-02-07
Completion
2025-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous

Indications