Atezolizumab Plus Bevacizumab Combined With Locoregional Therapies in Unresectable Hepatocellular Carcinoma (ISMIO-001)
NCT ID: NCT07204327
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1136 participants
OBSERVATIONAL
2020-10-28
2026-12-31
Brief Summary
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Detailed Description
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Locoregional therapies (LRTs) such as TACE, HAIC, TARE, ablation, and radiotherapy remain an integral part of uHCC management in the Asia-Pacific region, offering potential synergistic effects when combined with Atezo+Bev. However, there is a lack of robust real-world evidence describing the timing, sequencing, and outcomes of these combined strategies.
The ISMIO-001 study is designed as a retrospective, multicenter, real-world cohort study. Eligible patients must be ≥18 years old, diagnosed with uHCC, and treated with Atezo+Bev plus at least one LRT within ±2 months of Atezo+Bev initiation, between October 28, 2020 and July 31, 2025. The observation period will continue until October 31, 2025, with study completion anticipated by December 31, 2026.
The study will provide large-scale evidence on treatment patterns, overall survival, safety, and subgroup outcomes (e.g., by BCLC/CNLC stage, Child-Pugh class, ALBI grade, HBV vs. other etiologies). Findings will inform future clinical guidelines and support the optimization of treatment sequencing for uHCC in HBV-predominant populations.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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uHCC patients treated with Atezo+Bev plus LRT
Patients with unresectable hepatocellular carcinoma (uHCC) who received first-line atezolizumab plus bevacizumab (Atezo+Bev) in combination with at least one locoregional therapy (TACE, HAIC, TARE, ablation, or radiotherapy) within ±2 months of systemic therapy initiation, between October 28, 2020 and July 31, 2025.
Atezo+Bev plus Locoregional Therapy
Patients received atezolizumab plus bevacizumab (Atezo+Bev) in combination with at least one locoregional therapy (transarterial chemoembolization \[TACE\], hepatic arterial infusion chemotherapy \[HAIC\], transarterial radioembolization \[TARE\], ablation, or radiotherapy) within ±2 months of systemic therapy initiation, in routine clinical practice.
Interventions
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Atezo+Bev plus Locoregional Therapy
Patients received atezolizumab plus bevacizumab (Atezo+Bev) in combination with at least one locoregional therapy (transarterial chemoembolization \[TACE\], hepatic arterial infusion chemotherapy \[HAIC\], transarterial radioembolization \[TARE\], ablation, or radiotherapy) within ±2 months of systemic therapy initiation, in routine clinical practice.
Eligibility Criteria
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Inclusion Criteria
* Histologically or radiologically confirmed unresectable hepatocellular carcinoma (uHCC) according to national guidelines
* Initiated first-line Atezo+Bev treatment between October 28, 2020 and July 31, 2025
* Received ≥1 locoregional therapy (TACE, HAIC, TARE, ablation, or radiotherapy) within ±2 months of Atezo+Bev initiation
* At least one follow-up record available after treatment initiation
Exclusion Criteria
* Concurrent participation in interventional clinical trials at baseline
* Diagnosis of other malignancies at baseline (except basal cell carcinoma of the skin)
18 Years
ALL
No
Sponsors
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Zhongda Hospital
OTHER
Responsible Party
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Gao-jun Teng
Center of Interventional Radiology and Vascular Surgery
Locations
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Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CHANCE2510-ISMIO001
Identifier Type: -
Identifier Source: org_study_id
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