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)

PHASE3CompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

July 21, 2023

Primary Completion Date

February 7, 2025

Study Completion Date

February 7, 2025

Conditions
Biliary Tract Cancers
Interventions
DRUG

durvalumab

Durvalumab 1500 mg as a 60-minute IV infusion in combination with gemcitabine-based chemotherapy Q3W. Upon completing chemotherapy, or discontinuing chemotherapy due to toxicity, durvalumab 1500 mg IV Q4W alone or in combination with gemcitabine.

Trial Locations (19)

100142

Research Site, Beijing

100210

Research Site, Beijing

110001

Research Site, Shenyang

150049

Research Site, Harbin

200032

Research Site, Shanghai

230001

Research Site, Hefei

230022

Research Site, Hefei

250117

Research Site, Jinan

300050

Research Site, Tianjin

300060

Research Site, Tianjin

330000

Research Site, Nanchang

350011

Research Site, Fuzhou

361015

Research Site, Xiamen

400038

Research Site, Chongqing

410013

Research Site, Changsha

430030

Research Site, Wuhan

430071

Research Site, Wuhan

510280

Research Site, Guangzhou

710061

Research Site, Xi'an

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY