Safety and Efficacy of Folic Acid Combined With Atezolizumab and Bevacizumab as First-Line Therapy for Unresectable Hepatocellular Carcinoma

Summary

This study is evaluating the safety and potential effectiveness of adding folic acid to atezolizumab plus bevacizumab as first-line treatment for adults with unresectable hepatocellular carcinoma (HCC). The main questions this study aims to answer are: Is daily folic acid safe and well tolerated when given together with atezolizumab and bevacizumab? What dose of folic acid should be recommended for further study? Does the combination show sufficient antitumor activity to support further clinical testing? This is an open-label, single-arm phase Ib/II study. All participants will receive folic acid together with atezolizumab and bevacizumab. There is no placebo or separate control group. Participants will: Take folic acid by mouth once daily, starting 7 days before the first dose of atezolizumab and bevacizumab. Receive atezolizumab and bevacizumab by intravenous infusion every 3 weeks. Attend regular clinic visits for physical examinations, blood tests, safety assessments, and tumor imaging. Have tumor imaging every 6 weeks during the first 24 weeks and every 9 weeks thereafter. Provide blood samples for exploratory biomarker studies. An additional tumor biopsy during treatment may be offered but is optional. Treatment will continue until disease progression, unacceptable side effects, withdrawal of consent, or another protocol-defined reason for stopping treatment. Immunotherapy may be continued for up to 24 months.

Timeline

Start

2026-10-01

Primary completion

2029-10-01

Completion

2029-10-01

Drugs

Indications