NCT06717464

Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer

Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer, Phase II, Single-center, Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled study to evaluate the efficacy and safety of toripalimab plus capecitabine as postoperative adjuvant therapy for patients with resectable advanced extrahepatic biliary tract cancer.

Conditions

• Gallbladder Cancer
• Hilar Cholangiocarcinoma
• Distal Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine	1250mg/m2, D1-D14, q3w, for 24 weeks (8 cycles)
DRUG	Toripalimab	240mg intravenous injection, q3w, for 54 weeks (18 cycles)

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: China