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Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date changed from estimate of Dec 31, 2025 to Oct 8, 2026 Trial completed · Final enrollment: 243 participants (planned 1600) · Eligibility criteria expanded, about 8 words · 1 more Show 4 more changesShow less
    • Trial completed
    • Final enrollment: 243 participants (planned 1600)
    • Eligibility criteria expanded, about 8 words
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07091942
Lead Sponsor National Taiwan University Hospital
Collaborators: Taipei Veterans General Hospital, Taiwan, Chi Mei Medical Hospital, National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University, Taichung Veterans General Hospital, E-DA Hospital, Chiayi Christian Hospital, Srinagarind Hospital, Khon Kaen University
Conditions Hepatocellular Carcinoma
Enrollment 243 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov