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
Biliary Tract Cancers
18 Years - n/a
Endpoint Classification: -
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Verified 01 Jan 2024 by AstraZeneca
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.
The primary objective of the study is to assess the safety of durvalumab combined with gemcitabine-based chemotherapy for participants with advanced BTC who have not previously received systemic therapy for advanced or metastatic BTC with WHO/ECOG PS of 0 to 2. Eligible participants will received durvalumab in combination with gemcitabine-based chemotherapy(Gemcitabine+Oxalipatin; Gemcitabine+S1, Gemcitabine+Cisplatin) by investigator’s choice.
No locations available
|Experimental: durvalumab in combination with gemcitabine-based chemotherapy