AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

682

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

July 31, 2027

Study Completion Date

December 31, 2027

Conditions
Biliary Tract Cancer
Interventions
DRUG

AK112, Gemcitabine, Cisplatin

AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.

DRUG

Durvalumab, Gemcitabine, Cisplatin

Durvalumab will be administered at 1500mg intravenously (IV) every three weeks (Q3W) for 8 cycles and followed by monotherapy every 4 weeks. Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.

Trial Locations (2)

Unknown

Harbin Medical University Cancer Hospital, Harbin

Zhongshan Hospital, Fudan University, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Akeso

INDUSTRY