NCT05672537

Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk

Duvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk, Phase II, Single Center, Randomized Controlled Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized controlled study to evaluate the efficacy and safety of Durvalumab combined with GemCis for neoadjuvant treatment of high recurrence risk ICC

Conditions

• Durvalumab
• Intrahepatic Cholangiocarcinoma
• Gemcis

Interventions

Type	Name	Description
DRUG	Durvalumab	1500mg intravenous injection for 21d cycle
PROCEDURE	Surgery	Surgery
DRUG	Gemcitabine	gemcitabine 1000mg/m2, D1\&D8, 21d cycle.
DRUG	Cisplatin	cisplatin 25mg/m2, D1\&D8, 21d cycle.

Timeline

• Start date: 2023-01-20
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-01-05
• Last updated: 2023-01-05

Locations

1 site across 1 country: China