Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
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
Study ID: NCT05924880
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Changsha, , China
Research Site, Chongqing, , China
Research Site, Fuzhou, , China
Research Site, Guangzhou, , China
Research Site, Harbin, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Jinan, , China
Research Site, Nanchang, , China
Research Site, Shanghai, , China
Research Site, Shenyang, , China
Research Site, Tianjin, , China
Research Site, Tianjin, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Xiamen, , China
Contact Details
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