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Therasphere® and Systemic Therapy for Patients With Hepatocellular Carcinoma That is High-risk

NCT05620771 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-26

No results posted yet for this study

Summary

The purpose of this research is to compare progression free survival between two available systemic therapies - immunotherapy and tyrosine kinase inhibitors - after Therasphere® (yttrium-90) treatment in adult patients with advanced hepatocellular carcinoma. The immunotherapy consists of a standard-of-care treatment with Atezolizumab and Bevacizumab. Treatment with tyrosine kinase inhibitors consists of standard-of-care Lenvatinib or Cabozantinib.

Conditions

Interventions

DRUG

Y90 + Atezolizumab and Bevacizumab

Patients will receive Durvalumumab + Tremelimumab if Bevacizumab is contraindicated. Patients should begin systemic therapy anytime within 90 days after completion of Y-90 treatment. Treatment will continue until disease progression (clinical or radiological) or unacceptable toxicity/death. Patients will be continued on therapy till either progression is noted (clinical and/or radiological) or if patient is not tolerating therapy. However, there is the possibility of treatment beyond progression per PI discretion.

DRUG

Y90 + TKI

Patients should begin systemic therapy anytime within 90 days after completion of Y-90 treatment. Treatment will continue until disease progression (clinical or radiological) or unacceptable toxicity/death. Patients will be continued on therapy till either progression is noted (clinical and/or radiological) or if patient is not tolerating therapy. However, there is the possibility of treatment beyond progression per PI discretion.

Sponsors & Collaborators

Principal Investigators

  • Aparna Kalyan, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2040-07-01
Completion
2040-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05620771 on ClinicalTrials.gov