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) .

Spots Global Cancer Trial Database for Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

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