A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT06503250
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab — DRUGObservational Study
- Bevacizumab — DRUGObservational Study
- Transarterial Chemoembolization — RADIATIONObservational Study
Study Details
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.
Key Dates
- Start date
- Jul 19, 2024
- Status verified
- Mar 2025
- Primary completion
- Nov 27, 2024
- Completion
- Nov 27, 2024
Study Design
- Enrollment
- 113 participants (actual)
Arms
- Arm: Retrospective CohortSecondary data from medical records of approx 5 sites across China will be utilized. Patient identification period is between 28 Oct 2020 to 31 Dec 2023. The index date is defined as the earlier date of initiating Atezo+Bev or TACE after the initial diagnosis of unresectable HCC. Baseline period is defined as 60 days prior to the index date. Observation period is defined as the period from the index date until death, latest visit record during retrospective observation period, diagnosis of other primary cancer (except basal cell carcinoma), or 31 March 2024, whichever occurs first.
Primary Outcome Measure
Median Time to Real-World Progression-Free Survival (rwPFS) [ Time Frame: up to approximately 12 months ]
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