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.
3.1.1 Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD) guidelines with a Childs-Pugh score of A or B7 [Appendix 5] NOTE: If the patient does not have histological confirmation of disease by biopsy, diagnosis of HCC must be documented with approval by a tumor board or other multidisciplinary conference. Please refer to the appropriate source documents.
3.1.2 Patients must have at least 1 lesion that is measurable using RECIST guidelines. NOTE: A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST, and has clearly progressed.
3.1.3 Patients may be treatment -naïve or have received any number of prior therapies. NOTE: Prior cancer targeted immunotherapy for any other cancer is contraindicated and not permitted.
3.1.4 Adults ≥18 years old of either gender are eligible.
3.2.1 Patients who are concurrently enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study.
3.2.2 Patients who are receiving any other investigational agents within 28 days of registration.
3.2.3 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y-90, PD-1 &PD-L1 antagonists and TKI's. Note: Patients must not have a history of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of initiation of supportive care) to any unknown allergens or any components of the systemic therapy
3.2.4 Patients must not have had prior treatment any PDL1 or PD-1 antagonists.
Northwestern University
Lead sponsor
National Cancer Institute (NCI)
Collaborator