Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma: A Multinational Retrospective Study

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Time Frame
Start Date: 2025-07-17
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 1600
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Chiayi Christian Hospital, Srinagarind Hospital, Khon Kaen University, Taichung Veterans General Hospital, Chi Mei Medical Hospital, Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital Hsin-Chu Branch, E-DA Hospital, National Taiwan University
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov

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