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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 9, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Biliary Tract Neoplasms Immunotherapy
Interventions
DRUG

Pembrolizumab,Lenvatinib and Gemox Chemotherapy(Gemcitabine and Oxaliplatin)

Drug: Pembrolizumab Pembrolizumab 200 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.

DRUG

Pembrolizumab and Lenvatinib

Pembrolizumab and Lenvatinib

DRUG

Pembrolizumab and Gemox Chemotherapy(Gemcitabine and Oxaliplatin)

Pembrolizumab and Gemox Chemotherapy(Gemcitabine and Oxaliplatin)

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