Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 14, 2022

Primary Completion Date

December 30, 2023

Study Completion Date

December 30, 2024

Conditions
Biliary Tract NeoplasmsImmunotherapy
Interventions
DRUG

Durvalumab

Durvalumab 1500 mg will be administered intravenously once every three weeks, with intravenous infusion on Day 1 of each cycle.

DRUG

Lenvatinib Oral Product

The dose of lenvatinib is 12mg/day for patients with a body weight of ≥60 kg, and 8mg/day for patients with a body weight of \<60 kg, taken once daily.

DRUG

Chemotherapy

GEMOX regimen: Gemcitabine 1000mg/m2 will be administered intravenously over 30 minutes on Day 1 and Day 8; Oxaliplatin 100mg/m2 will be administered intravenously over 2 hours on Day 1, and the cycle will be repeated every 3 weeks.

Trial Locations (1)

100730

RECRUITING

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH), Beijing

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER