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

Conditions

• Hepatocellular Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Y90 + Atezolizumab and Bevacizumab — DRUG
  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.
• Y90 + TKI — DRUG
  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.

Study Details

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.

Key Dates

Start date

Nov 30, 2022

Status verified

May 2026

Primary completion

Jul 1, 2040

Completion

Jul 1, 2040

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Y90 + Atezolizumab and Bevacizumab
• Experimental: Y90 + TKI

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]

Central Contacts

• Study Coordinator
  3126951301
  [email protected]

Locations (7)

Find similar trials in Chicago, IL

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