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

Sponsor: Tianjin Medical University Cancer Institute and Hospital
Study ID: NCT05672537
Phase: PHASE2
Status: Unknown

Conditions

Durvalumab
Gemcis
Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - 75 Years
Healthy Volunteers: Accepted

Interventions

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

Study Details

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

Key Dates

Start date: Jan 20, 2023
Status verified: Jan 2023
Primary completion: Dec 31, 2024
Completion: Dec 31, 2025

Study Design

Enrollment: 70 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Durvalumab Combined with GemCis Neoadjuvant Therapy Group
Experimental: Surgical treatment group

Primary Outcome Measure

1-year relapse free survival rate [ Time Frame: 1-year ]

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