Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Lenvatinib

Cisplatin

Oxaliplatin

Protein Kinase Inhibitors

Enzyme Inhibitors

Toripalimab 240mg, intravenous infusion every 3 weeks until disease progression or occurrence of intolerable toxicity.

Toripalimab

When the body weight is ≥60 kg, the dosage of Lenvatinib is 12mg qd, when body weight \< 60kg the dosage is 8mg qd.

Chemotherapy drugs: GC regimen is preferred, and if patients cannot tolerate it, GEMOX regimen is used.

Gemcitabine + oxaliplatin (GEMOX) regimen chemotherapy: every 21 days (3 weeks), 1000 mg/m2 of gemcitabine was administered intravenously for more than 30 min on the 1st and 8th day, and 100 mg/m2 of oxaliplatin was administered intravenously for 2h on the 1st day Gemcitabine + cisplatin (GC) regimen chemotherapy: 1250 mg/m2 was administered intravenously for 30 min on day 1 and day 8, respectively, and 100 mg/m2 was administered intravenously for 2 hours after gemcitabine treatment on day 1.

Gemox Chemotherapy（Gemox or GC）

Haitao Zhao, PhD

Haitao Zhao, Professor

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

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

DCR 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)

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.

The time from randomization to death due to any cause in the subjects

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

The ratio of subjects who achieve complete response (CR) or partial response (PR) or maintain stable disease (SD) .

Peking Union Medical College Hospital

Pembrolizumab

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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 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：Pembrolizumab Pembrolizumab 200 mg will be administered intravenously once every three weeks, with intravenous infusion on Day 1 of each cycle. Drug: GEMOX 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 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,Lenvatinib and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）

Pembrolizumab and Lenvatinib

Pembrolizumab and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）

haitao Zhao, Ph.D

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

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.

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

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)

The percentage of patients who have not experienced disease progression or death due to any cause after receiving the therapy, among the evaluable patients for efficacy.

The percentage of patients who died due to any cause after receiving therapy among all enrolled patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer	NCT06362317	Biliary Tract N...	Toripalimab Lenvatinib Gemox Chemother...	18 Years - 75 Years	Peking Union Medical College Hospital
Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer	NCT06230471	Biliary Tract N...	Pembrolizumab,L... Pembrolizumab a... Pembrolizumab a...	18 Years - 80 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for biliary tract neoplasms immunotherapy