Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk
NCT05672537 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2023-01-05
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
- DRUG
-
1500mg intravenous injection for 21d cycle
- PROCEDURE
-
Surgery
Surgery
- DRUG
-
gemcitabine 1000mg/m2, D1\&D8, 21d cycle.
- DRUG
-
cisplatin 25mg/m2, D1\&D8, 21d cycle.
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-01-20
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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