NCT06362317

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Biliary Tract Neoplasms Immunotherapy

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240mg, intravenous infusion every 3 weeks until disease progression or occurrence of intolerable toxicity.
DRUG	Lenvatinib	When the body weight is ≥60 kg, the dosage of Lenvatinib is 12mg qd, when body weight \< 60kg the dosage is 8mg qd.
DRUG	Gemox Chemotherapy（Gemox or GC）	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.

Timeline

• Start date: 2024-03-06
• Primary completion: 2025-03-06
• Completion: 2026-03-06
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: China