Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

Sponsor
University Health Network, Toronto
Study ID
NCT06725121
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab & Bevacizumab — BIOLOGICAL
    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.
  • Yttrium-90 (Y-90) — DRUG
    Storage, administration and treatment of Y90-RE will be done according to established treatment protocols and standard of care at UHN.
  • Stereotactic body radiotherapy (SBRT) — RADIATION
    Dose and administration frequency of SBRT will be done as per current standards for treating HCC at UHN.

Study Details

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.

Key Dates

Start date
Dec 31, 2024
Status verified
Dec 2024
Primary completion
Jun 30, 2031
Completion
Jun 30, 2034

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Treatment
    This is a pilot, single-arm study enrolling 48 patients to evaluate the feasibility of locoregional therapy followed by immunotherapy in patients with advanced liver cancer. Patients will receive stereotactic body radiotherapy or Yttrium-90 radioembolization as per the standard-of-care (SOC) protocol, determined during Multidisciplinary Rounds. Starting two to six weeks after radiotherapy, patients will begin treatment with Atezolizumab and Bevacizumab administered in approximately 21-day intervals, following SOC procedures, for a maximum of 9 months. Clinical follow-up will align with SOC protocols, and imaging will be performed every 2-3 months during immunotherapy. If a patient is sufficiently responding to treatment at any follow-up, patients will be referred for transplant evaluation and added to the waitlist if no contraindications are found. Patients with disease progression or who become ineligible for LT due to other factors will be transitioned off the study.

Primary Outcome Measure

Evaluate Downstaging Efficacy [ Time Frame: From enrollment to liver transplantation. ]

Central Contacts

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