Actively Recruiting
Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma
Led by National Taiwan University Hospital · Updated on 2025-07-29
1600
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
T
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hepatocellular carcinoma by biopsy or clinical imaging
- Received atezolizumab plus bevacizumab as first-line systemic therapy for HCC
- Allowed with or without macrovascular invasion or main portal vein invasion before treatment
- Allowed with or without extrahepatic spread before treatment
- Achieved complete or partial response according to RECIST version 1.1 after treatment
You will not qualify if you...
- Diagnosis of fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- Received anti-CTLA4 antibodies simultaneously with atezolizumab plus bevacizumab
- Received locoregional therapies like transarterial chemoembolization, hepatic arterial infusion chemotherapy, radioembolization, or ablation before achieving partial response or not for curative intent
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Select, Taiwan, 10002
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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