NCT04857684

SBRT + Atezolizumab + Bevacizumab in Resectable HCC

A Pilot Study of Neoadjuvant Stereotactic Beam Radiation Therapy Followed by Atezolizumab and Bevacizumab in Resectable Hepatocellular Carcinoma

• Status: Active Not Recruiting
• Phase: EARLY_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 study is evaluating the safety and tolerability of neoadjuvant stereotactic body radiation therapy (SBRT) with atezolizumab and bevacizumab for treating resectable hepatocellular carcinoma. This study involves the following study interventions: * Atezolizumab * Bevacizumab * Stereotactic Beam Radiation Therapy (SBRT) * Surgery

Detailed description

This is a single-center, open-label, single-arm pilot study designed to evaluate the safety and tolerability of neoadjuvant radiation therapy plus atezolizumab and bevacizumab in patients with treatment-naïve resectable hepatocellular carcinoma. This research study is a Pilot Study, which is the first-time investigators are examining this intervention of neoadjuvant radiation therapy plus atezolizumab and bevacizumab. The U.S. Food and Drug Administration (FDA) has not approved atezolizumab, bevacizumab, stereotactic body radiation therapy (SBRT) for resectable hepatocellular carcinoma but they have been approved for other uses. Surgery is an accepted and standard treatment option for resectable hepatocellular carcinoma The study interventions (atezolizumab bevacizumab, and SBRT) are thought to increase the immune system's (the system in the body that fights against disease) response to cancer cells. These interventions may increase the immune system's response by helping the T cells (an immune cell that identifies and attacks infected cells) recognize and find cancer cells in the body. By increasing the system's response, it is believed the chances of recurrence of resectable hepatocellular carcinoma will be less than when only standard of care surgery is used. The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits. Participants will receive study treatment for as long as they and their doctor believe they are benefitting from the study interventions and will be followed for 5 years or until participants withdraw their consent to be contacted. It is expected that about 20 people will take part in this research study

Conditions

• Hepatocellular Carcinoma
• Resectable Hepatocellular Carcinoma

Interventions

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

Timeline

• Start date: 2021-06-18
• Primary completion: 2026-04-29
• Completion: 2027-04-29
• First posted: 2021-04-23
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study