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Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant

NCT06725121 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-12-16

No results posted yet for this study

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

Interventions

BIOLOGICAL

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.

DRUG

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.

RADIATION

Stereotactic body radiotherapy (SBRT)

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

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Gonzalo Sapisochin, MD, PhD, MSc · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2031-06-30
Completion
2034-06-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725121 on ClinicalTrials.gov