Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hepatocellular Carcinoma
  • Resectable Hepatocellular Carcinoma
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 fir...

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

Tracking Information

NCT #
NCT04857684
Collaborators
Genentech, Inc.
Investigators
Principal Investigator: Joseph W Franses, MD, PhD Massachusetts General Hospital