Downstaging of Hepatocellular Carcinoma with Macrovascular Invasion by Radiotherapy (SBRT or Y90) and Atezolizumab Plus Bevacizumab Followed by Liver Transplantation - a Prospective Trial (MacroTrans)

NCT06725121 Phase 1/Phase 2 RECRUITING

The goal of this clinical trial is to learn if locoregional therapy and immunotherapy can be used together to help patients with hepatocellular carcinoma (HCC) and macrovascular invasion achieve liver transplantation. The main questions it aims to answer are: * How many patients will achieve transplant with this treatment strategy? * What will the 5-year survival and recurrence-free survival rates be for these patients? Participants will: * Undergo a biopsy of the tumor. * Receive locoregional therapy (SBRT or Y90) followed by immunotherapy (atezolizumab and bevacizumab) 2 to 6 weeks later, for a maximum of 9 months. * Be referred for a liver transplant and undergo the procedure if deemed eligible and safe. * If applicable, be followed for five years post-transplant with regular data collection.

Details

Lead sponsor	University Health Network, Toronto
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	48
Start date	2024-12
Completion	2034-06

Conditions

• Hepatocellular Carcinoma (HCC)
• Macrovascular Invasion
• Liver Transplant Surgery
• Downstaging

Interventions

• Atezolizumab & Bevacizumab
• Yttrium-90 (Y-90)
• Stereotactic body radiotherapy (SBRT)

Primary outcomes

• Evaluate Downstaging Efficacy — From enrollment to liver transplantation.
  The number of patients who achieve a liver transplant.

Countries

Canada