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Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

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

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 70

Participation Criteria

Inclusion Criteria:

* Age 18-70
* Weight \> 30 kg
* Child Pugh Turcotte score A5 to B7
* Macrovascular invasion (Vp1-3)
* Total tumour volume \< 350 cm3
* Alpha Fetoprotein \< 5000 ng/mL
* No extrahepatic disease
* No other contraindications to undergo a LT
* Eastern Cooperative Oncology Group (ECOG) score 0-1
* Capable to provide inform consent
* Radiological and histological confirmation of hepatocellular carcinoma

Exclusion Criteria:

* Poorly differentiated HCC
* Prior therapy for hepatocellular carcinoma other than liver resection or ablation
* Portal vein tumor thrombus extending beyond main portal vein
* Obesity class III (BMI ≥ 40 kg/m2)
* Contraindications for radiotherapy (Y90 or SBRT) or AtezoBev

Study Location

Toronto General Hospital
Toronto General Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Clinical Research Manager

[email protected]
437-772-4354
London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contact Study Team

Primary Contact

Clinical Research Manager

[email protected]
519-685-8500
Backup Contact

Surgical Director of Liver Transplantation, MD, PhD

Study Sponsored By
University Health Network, Toronto
Participants Required
More Information
Study ID: NCT06725121