NCT06721286

Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma

Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma (ICC) With High Risk of Recurrence, Phase II, Single-center, Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.

Conditions

• Intrahepatic Cholangiocarcinoma (Icc)

Interventions

Type	Name	Description
DRUG	Teripalimab	240mg intravenous injection, D1, q3w, for 9 weeks (3 cycles)
DRUG	Gemcitabine + Cisplatin	Gemcitabine 1000mg/m2 + cisplatin 25mg/m2, D1\&D8, q3w, for 9 weeks (3 cycles)
PROCEDURE	Surgery	Radical resection

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-12-06
• Last updated: 2024-12-06

Locations

1 site across 1 country: China