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) - TopDouble

Study identifier:D933AL00006

ClinicalTrials.gov identifier:NCT05924880

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase IIIb, Single Arm, Open-label, Multi-center Study on Durvalumab in Combination with Gemcitabine-based Chemotherapy as First Line Treatment for Chinese Patients with unresectable Biliary Tract Cancers

Medical condition

Biliary Tract Cancers

Phase

Phase 3

Healthy volunteers

No

Study drug

durvalumab

Sex

All

Estimated Enrollment

115

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 21 Jul 2023
Estimated Primary Completion Date: 30 Oct 2024
Estimated Study Completion Date: 31 May 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria