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

NCT07204327 | Active Not Recruiting

• 1 other identifier: CHANCE2510-ISMIO001
• Study Type: observational
• Target: 1,136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Unresectable Hepatocellular Carcinoma; Atezolizumab; Bevacizumab; Unresectable HCC; Locoregional Therapy; TACE; HAIC; TARE; Ablation; Real-world; HBV; Asia-Pacific

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival, defined as the time from initiation of atezolizumab plus bevacizumab treatment to death from any cause.

  Up to 36 months (median follow-up period anticipated)

Secondary Outcomes (7)

• Real-world Progression-Free Survival (rwPFS)

  Up to 36 months

• Objective Response Rate (ORR)

  Up to 36 months

• Disease Control Rate (DCR)

  Up to 36 months

• Time to Treatment Discontinuation (TTD)

  Up to 36 months

• Time to Next Treatment (TTNT)

  Up to 36 months

Study Arms (1)

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.

Other: Atezo+Bev plus Locoregional Therapy

Interventions

Atezo+Bev plus Locoregional Therapy OTHER

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.

uHCC patients treated with Atezo+Bev plus LRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable hepatocellular carcinoma (uHCC) treated in routine clinical practice across multiple centers in China and the Asia-Pacific region, receiving atezolizumab plus bevacizumab in combination with locoregional therapies.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center of Interventional Radiology and Vascular Surgery

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 28, 2020
• Primary Completion: October 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CN (1)