Clinical Trials Logo

Clinical Trial 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)


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05096715
Study type Interventional
Source Massachusetts General Hospital
Contact Jennifer Y Wo, MD
Phone (617) 726-6050
Email jwo@mgh.harvard.edu
Status Not yet recruiting
Phase Phase 1
Start date January 2022
Completion date January 1, 2026

See also
  Status Clinical Trial Phase
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Completed NCT00988741 - Trial of ARQ 197 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Who Have Failed One Prior Systemic Therapy Phase 2
Recruiting NCT03942328 - Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer Phase 1/Phase 2
Completed NCT01900002 - Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery Phase 2
Completed NCT06315101 - Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China
Not yet recruiting NCT04947956 - Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma
Completed NCT01004978 - Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery Phase 3
Active, not recruiting NCT01217034 - Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib Phase 2
Terminated NCT03695250 - BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer Phase 1/Phase 2
Completed NCT02006030 - Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma Phase 2
Active, not recruiting NCT03896646 - Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D) N/A
Recruiting NCT05135364 - HAIC Combined With Camrelizumab and TKI for Unresectable Hepatocellular Carcinoma After TACE Failure Phase 2
Recruiting NCT06117891 - An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery
Recruiting NCT05957640 - Yttrium-90 Carbon Microspheres in Patients With Unresectable Hepatocellular Carcinoma Phase 1
Recruiting NCT04736121 - Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients N/A
Recruiting NCT05168163 - Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer Phase 2
Withdrawn NCT03345225 - A Clinical Study of Precision TACE (P-TACE) With Surefire N/A
Recruiting NCT05667064 - Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
Recruiting NCT05269381 - Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors Phase 1/Phase 2
Withdrawn NCT02989870 - Sorafenib and Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma Phase 1