A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization
NCT Number: NCT06503250
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Unresectable Hepatocellular Carcinoma
Interventions: DRUG: Atezolizumab|DRUG: Bevacizumab|RADIATION: Transarterial Chemoembolization
Sponsor: Hoffmann-La Roche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-19
Completion Date: 2025-09-30
Locations: The First Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510080, China

Summary:
This is a multicenter, retrospective, observational cohort study to describe the effectiveness and safety of Atezo+Bev plus Transarterial Chemoembolization (TACE) among adult patients with unresectable hepatocellular carcinoma (HCC) in real-world clinical practice in China. Eligible patients diagnosed with unresectable HCC initiating the Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 will be included in this study.

Primary Outcome Measures: Median Time to Real-World Progression-Free Survival (rwPFS), rwPFS is defined as time from the index date to the first evidence of clinician-assessed progressive disease (may include but are not limited to local tumor progression, disease recurrence, new metastasis, or clinical progression anchored by clinicians) or death from any cause., up to approximately 12 months
Secondary Outcome Measures: Median Time to Real-World Overall Survival (rwOS), rwOS is defined as time from the index date to death from any cause., up to approximately 3 years|Median Time to Real-World Overall Response Rate (rwORR), rwORR is defined as the percentage of patients who achieved complete response (CR) or partial response (PR) after the initiation of both Atezo+Bev and TACE among patients with at least one response assessment result after the initiation of both Atezo+Bev and TACE, with reference to the assessment of tumor lesions within 60 days prior to the later initiation of Atezo+Bev or TACE., up to approximately 3 years|Percentage of Participants with Serum Alpha-Fetoprotein (AFP) Reduction, AFP reduction is defined as \> 50% reduction in AFP level after 3 months (± 4 weeks) of the later initiation of Atezo+Bev or TACE., up to approximately 4 years|Percentage of Participants with Prothrombin Induced by the Absence of Vitamin K or Antagonist-II (PIVKA-II) Reduction:, PIVKA-II reduction is defined as \> 50% reduction in PIVKA-II level after 3 months (± 4 weeks) of the later initiation of Atezo+Bev or TACE., up to approximately 4 years|Percentage of Participants with Surgical Resection, Conversion rate (surgical resection) is defined as the percentage of patients who underwent surgical resection of tumor among patients who completed the Atezo+Bev plus TACE treatment by the end of observation period., up to approximately 4 years|Percentage of Participants with Adverse Events, The adverse events of interest include liver function abnormality, renal function abnormality, hemorrhage, hypertension, hepatitis virus reactivation and immune-related adverse events., up to approximately 4 years