Phase II Study Therasphere® (Yttrium-90) in Combination With Systemic Therapy in Patients With High-risk Hepatocellular Carcinoma

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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.

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