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RecruitingPhase 1Phase 2NCT06725121

Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

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

Sponsor

University Health Network, Toronto

Enrollment

48 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma (HCC)Liver Transplant SurgeryMacrovascular InvasionDownstaging

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether combining radiotherapy and immunotherapy before a liver transplant can help advanced liver cancer patients become eligible for transplant, improving their long-term survival. **You may be eligible if...** - Age 18–70, weighing over 30 kg - Have liver cancer (hepatocellular carcinoma) with blood vessel invasion (macrovascular invasion, Vp1–3) - Have reasonably preserved liver function (Child-Pugh score A5 to B7) - Total tumor volume under 350 cm³ and AFP (tumor marker) under 5000 ng/mL - No cancer spread outside the liver - Considered a potential liver transplant candidate **You may NOT be eligible if...** - Cancer has spread outside the liver - Have too much liver damage (Child-Pugh C) - Are not a candidate for liver transplant for other medical reasons - Have blood vessel invasion beyond Vp3 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab & 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.

DRUGYttrium-90 (Y-90)

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

RADIATIONStereotactic 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

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NCT06725121

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