Recruiting
Phase 1
Phase 2

Radiotherapy & Immunotherapy

Sponsor:

University Health Network, Toronto

Code:

NCT06725121

Conditions

Hepatocellular Carcinoma (HCC)

Macrovascular Invasion

Liver Transplant Surgery

Downstaging

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Atezolizumab & Bevacizumab

Yttrium-90 (Y-90)

Stereotactic body radiotherapy (SBRT)

Study Details

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Macrovascular Invasion

Liver Transplant Surgery

Downstaging

Study ID

NCT06725121

Start date

Dec, 2024

Status verified date

Dec, 2024

Completion date

Jun, 2034

Anticipated

Primary completion date

Jun, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Stereotactic body radiotherapy (SBRT)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Research Manager

437-772-4354roxana.bucur@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Clinical Research Manager

437-772-4354roxana.bucur@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 16, 2024

Last verified

Dec, 2024

Keywords

  • SBRT
  • Y-90
  • Yittrium-90
  • Atezolizumab
  • Bevacizumab
  • Advanced liver cancer
  • Radiotherapy
  • Immunotherapy
  • Liver cancer
  • Stereotactic body radiotherapy
  • Transplant
  • Liver Transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-12-16.