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RECRUITING
NCT06725121
PHASE1/PHASE2

Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-12

Completion Date

2034-06

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

Atezolizumab & Bevacizumab

Atezolizumab \& Bevacizumab will be initiated as part of the study, as per standard treatment protocol. Administration of Atezolizumab and Bevacizumab will be performed according to SOC in approx. 21-days intervals. Clinical follow up during treatment will be done as per SOC in medical and surgical oncology clinics at UHN.

DRUG

Yttrium-90 (Y-90)

Storage, administration and treatment of Y90-RE will be done according to established treatment protocols and standard of care at UHN.

RADIATION

Stereotactic body radiotherapy (SBRT)

Dose and administration frequency of SBRT will be done as per current standards for treating HCC at UHN.

Locations (2)

London Health Sciences Centre

London, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada