NCT05096715

Atezolizumab+Bevacizumab+SBRT in Unresectable HCC

Phase IB Study of Atezolizumab and Bevacizumab With SBRT for Unresectable Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating the safety and tolerability of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable hepatocellular carcinoma. This study involves the following interventions: * Atezolizumab * Bevacizumab * Stereotactic body radiation therapy (SBRT)

Detailed description

This is a single-arm phase 1B study designed to evaluate the combination of Atezolizumab and Bevacizumab with stereotactic body radiation therapy (SBRT for treating and limiting the recurrence of unresectable hepatocellular carcinoma. The U.S. Food and Drug Administration (FDA) has approved atezolizumab and bevacizumab for unresectable hepatocellular carcinoma. The FDA has not approved the combination of radiation therapy, atezolizumab, and bevacizumab. Atezolizumab is believed to work by increasing the immune system's response to cancer cells. Bevacizumab is believed to work by inhibiting cancer cells from growing by targeting a specific protein in the cancer cells. Radiation therapy is a standard of care treatment for unresectable hepatocellular carcinoma. Radiation therapy has also been shown to increase the effects of drugs like atezolizumab and bevacizumab. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be in this research study for as long as the study drugs are safe and beneficial to them. Participants will then be followed for up to 5 years. It is expected that about 20-32 people will take part in this research study. Genentech, a biotechnology company, is supporting this research study by providing funding for the study, including the study drugs.

Conditions

• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Intravenous Infusion
DRUG	Bevacizumab	Intravenous Infusion
RADIATION	Stereotactic body radiation therapy (SBRT)	External Beam Radiation

Timeline

• Start date: 2022-08-23
• Primary completion: 2027-01-31
• Completion: 2032-01-31
• First posted: 2021-10-27
• Last updated: 2026-02-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study