Phase IB Study of Atezolizumab and Bevacizumab With SBRT for Unresectable Hepatocellular Carcinoma
Massachusetts General Hospital
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)
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 c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have diagnosis of hepatocellular carcinoma (HCC) that is deemed unsuitable for surgical resection, transplant, or radiofrequency ablation (RFA). Participants may have up to 5 lesions with a total maximal tumor dimension of \< 20 cm, and no one lesion \> 15 cm. Diagnosis may be confirmed by at least 1 criteria listed below: * Histologically or cytologically proven diagnosis of HCC within 180 days prior to study registration. * At least 1 solid liver lesion or vascular tumor thrombus (involving portal vein, IVC, and/or hepatic vein) \> 1 cm with arte…
Interventions
- DrugAtezolizumab
Intravenous Infusion
- DrugBevacizumab
Intravenous Infusion
- RadiationStereotactic body radiation therapy (SBRT)
External Beam Radiation
Locations (3)
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts