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
• The subjects voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.
They are over 18 years of age and gender is not restricted when signing the informed consent form.
They have histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
Patients who are diagnosed with unresectable or metastatic disease and have not received prior treatment are eligible for inclusion.
• Previous systemic treatment received.
ECOG score > 1.
Pancreatic cancer.
Pregnant (positive pregnancy test before medication) or breastfeeding women.
Parallel
Pembrolizumab,Lenvatinib and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）
DrugDrug: 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
DrugPembrolizumab and Lenvatinib
Pembrolizumab and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）
DrugPembrolizumab and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）
Objective response rate
Objective response rate
Disease control rate
t refers to the proportion of patients whose tumor volume control (shrinkage or enlargement) reaches a predetermined value and can maintain the minimum required duration. According to the RECIST criteria (version 1.1), during the treatment period or within 30 days after the discontinuation of the investigational drug, it is the sum of the percentage of subjects who achieve complete response (CR), partial response (PR), and stable disease (SD)
Progression-free survival
It refers to the time from the first administration of the regimen to the first occurrence of disease progression or death due to any cause in the subjects.
Overall survival
The time from randomization to death due to any cause in the subjects
Duration of response
It refers to the time from the first report of objective tumor partial or complete response (based on the earlier occurrence) to the first occurrence of disease progression or death in the subjects
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