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

NCT07204327 · tracked via the Priya Life Science China tracker

Sponsor

Zhongda Hospital

Phase

Observational

Started

2020-10-28

Last updated

2025-10-02

Condition(s) studied

Unresectable Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Atezo+Bev plus Locoregional Therapy

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥18 years at initiation of atezolizumab plus bevacizumab (Atezo+Bev) * 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: * Prior systemic therapy for HCC before Atezo+Bev initiation * Concurrent participation in interventional clinical trials at baseline * Diagnosis of other malignancies at baseline (except basal cell carcinoma of the skin)

Primary outcome measure(s)

Overall Survival (OS) — Up to 36 months (median follow-up period anticipated)
Overall survival, defined as the time from initiation of atezolizumab plus bevacizumab treatment to death from any cause.

Trial sites (1)

Facility	City	Region	Status
Zhongda Hospital, Southeast University	Nanjing	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204327 on ClinicalTrials.gov ↗ ← All trials in China