Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma

NCT07091942 | Recruiting

• 1 other identifier: 202504033RIPE
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Combination immunotherapy is currently the standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Approximately 30 % of patients treated with atezolizumab plus bevacizumab (Atezo-Bev) achieve complete or partial tumor response. Some patients who reach a partial response experience enough tumor regression to undergo curative therapies and subsequently attain a disease-free state. However, whether the prognosis of patients who become disease-free after curative therapy equals that of patients who achieve complete response with Atezo-Bev alone is unclear. Likewise, it remains uncertain whether patients who achieve partial response with Atezo-Bev and later undergo curative therapy fare better than those who remain in partial response without further curative treatment. Therefore, we designed this multinational, multicenter, retrospective chart-review study to address these questions. Planned Cohorts

• Curative-therapy cohort: Patients with unresectable HCC who achieve partial response to Atezo-Bev and subsequently receive curative therapy-surgical resection, radiofrequency ablation, or definitive radiotherapy-to achieve a disease-free state.
• Control cohort: Patients with unresectable HCC who achieve complete or partial response to Atezo-Bev but do not undergo subsequent curative therapy. Methods and End-points Data will be collected from no more than 30 hospitals worldwide, targeting roughly 400 patients in the curative-therapy cohort and 1,200 patients in the control cohort. Medical-record review will gather baseline characteristics, disease status, liver function, Atezo-Bev treatment details, curative-therapy specifics, treatment responses, and survival outcomes. The primary objective is to compare recurrence-free survival between the two cohorts. This retrospective study will close data collection on 31 March 2025.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  From initiation of atezolizumab-bevacizumab treatment to disease recurrence or date of death from any cause, whichever came first, assessed up to 8 years

Study Arms (2)

Curative LRT cohort

Patients who received curative locoregional therapy after obtaining partial response after atezolizumab-bevacizumab treatment

Comparative cohort

Patients who obtained completed or partial response after atezolizumab-bevacizumab treatment and did not receive curative locoregional therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who obtained CR or PR, according to RECIST version 1.1, after receiving Atezo-Bev as first-line systemic therapy for clinically or histologically diagnosed HCC

You may qualify if:

• Histologically or clinically (the presence of liver cirrhosis and typical HCC imaging findings by multi-phase CT or MRI) diagnosed HCC.
• Received Atezo-Bev containing treatment as first-line systemic therapy for HCC
• Patients with or without macrovascular invasion and main portal vein invasion before Atezo-Bev containing treatment can be enrolled
• Patients with or without extrahepatic spread before Atezo-Bev containing treatment can be enrolled
• Obtained CR or PR, according to RECIST version 1.1, to Atezo-Bev treatment

You may not qualify if:

• Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
• Received anti-CTLA4 antibodies simultaneously with Atezo-Bev Patients who received Atezo-Bev in combination with investigational drugs such as tiragolumab, relatlimab, and tocilizumab were allowed to enter the study.
• Received locoregional therapy simultaneously with Atezo-Bev treatment, such as transarterial chemoembolization (TACE), hepatic arterial infusion of chemotherapy (HAIC), transarterial radioembolization, radiofrequency ablation, and microwave ablation before obtaining PR or not for curative intent

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• Chi Mei Medical Hospital: collaborator
• National Taiwan University Hospital Hsin-Chu Branch: collaborator
• National Taiwan University: collaborator
• Taichung Veterans General Hospital: collaborator
• E-DA Hospital: collaborator
• Chiayi Christian Hospital: collaborator
• Srinagarind Hospital, Khon Kaen University: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Select, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 29, 2025
• Study Start: July 17, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

TW (1)