Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Health Network, Toronto

About this trial

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 criteria

Qualifiers

Age 18-70

Weight > 30 kg

Child Pugh Turcotte score A5 to B7

Macrovascular invasion (Vp1-3)

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

48 Participants
are divided into 1 treatment group