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
Peking Union Medical College Hospital
60 participants
Jan 9, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
Pembrolizumab and Lenvatinib
Pembrolizumab and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）
Locations(1)
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NCT06230471