Clinical Trial

Atezolizumab Plus Bevacizumab Combined With Locoregional Therapies in Unresectable Hepatocellular Carcinoma (ISMIO-001)

Study acronym: ISMIO001
Active, Not Recruiting
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Record status
This record was last updated October 2, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a retrospective, multicenter, real-world cohort study designed to evaluate the effectiveness and safety of atezolizumab plus bevacizumab (Atezo+Bev) combined with various locoregional therapies (LRTs), including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE), ablation, and radiotherapy, in patients with unresectable hepatocellular carcinoma (uHCC). Approximately 1,136 patients treated between October 28, 2020 and October 31, 2025 will be included from about 35 sites across China and the Asia-Pacific region. The primary endpoint is overall survival (OS). Secondary endpoints include real-world progression-free survival (rwPFS), overall response rate (ORR), disease control rate (DCR), time to discontinuation (TTD), time to next treatment (TTNT), time to progression (TTP), and safety outcomes. Exploratory analyses will assess associations between baseline patient characteristics, treatment patterns, and clinical outcomes.
Trial Details
NCT Number NCT07204327
Lead Sponsor Zhongda Hospital
Conditions Unresectable Hepatocellular Carcinoma
Enrollment 1,136 participants
Start Date 2020-10-28
Primary Completion 2025-10-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-02