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

PHASE2RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 6, 2024

Primary Completion Date

March 6, 2025

Study Completion Date

March 6, 2026

Conditions
Biliary Tract Neoplasms Immunotherapy
Interventions
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."

Trial Locations (1)

100005

RECRUITING

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH), Beijing

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER