NCT06230471

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

A Phase II, Multicenter, Randomized Study of Pembrolizumab With or Without Chemotherapy or Lenvatinib in First-Line Treatment of Advanced Biliary Tract Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Explore the impact of the first-line application of Pembrolizumab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers

Detailed description

This trial is a three-arm, randomized, multi-center clinical study. Eligible subjects who meet the study criteria will be screened and randomized in a 1:1:1 ratio to receive treatment with intravenous infusion of Pembrolizumab with or without chemotherapy and oral lenvatinib. The investigators will closely follow up and assess the efficacy and safety of the combined treatment, evaluate the progression-free survival of the subjects until progression occurs, and observe their overall survival as a secondary outcome.

Conditions

• Biliary Tract Neoplasms Immunotherapy

Interventions

Type	Name	Description
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）

Timeline

• Start date: 2023-01-09
• Primary completion: 2025-12-31
• Completion: 2026-04-30
• First posted: 2024-01-30
• Last updated: 2025-12-09

Locations

1 site across 1 country: China