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

NCT05620771 | Suspended Phase 2 DMC FDA Drug

• 3 other identifiers: NU 22I07NCI-2022-09476P30CA060553
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  To compare PFS by RECIST v1.1 criteria, with Y90 followed by immunotherapy (atezolizumab + bevacizumab, Arm A) or Y90 followed by TKI treatment (lenvatinib or cabozantinib, Arm B). Progression is defined as either radiological progression (with MRI or CT scan) OR clinical progression.

  Up to 2 years

Secondary Outcomes (6)

• Time to Progression (TTP)

  Up to 2 years

• Objective Response Rate (ORR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Clinical Benefit Rates (CBR)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

Study Arms (2)

Y90 + Atezolizumab and Bevacizumab

EXPERIMENTAL

Drug: Atezolizumab and Bevacizumab

Y90 + TKI

EXPERIMENTAL

Drug: Y90 + TKI

Interventions

Atezolizumab and Bevacizumab DRUG

Patients will receive atezolizumab + Bevacizumab for 21 days after standard of care therapy is complete.

Y90 + Atezolizumab and Bevacizumab

Y90 + TKI DRUG

Patients will receive TKI for 21 days after standard of care therapy is complete.

Y90 + TKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• 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.
• Patients must have advanced disease that is not amenable to transplant or resection.
• Patients may be treatment naïve or have received any number of prior therapies. NOTE:
• Prior cancer targeted immunotherapy is contraindicated and not permitted.
• Patients must exhibit an ECOG performance status of 0, 1, or 2 \[Appendix 1\]
• Patients must have adequate organ function prior to registration as determined by:
• Adequate organ function parameters:
• HEMATOLOGICAL (without growth factor support)
• Hemoglobin (HgB) ≥ 8.5 g/dL (without the use of growth factors) \[transfusion permitted\]
• Absolute Neutrophil Count (ANC) ≥1000 microliter (µL)
• Platelet Count ≥ 50 x 109/L (without use of growth factors \[i.e., IL-11 \] \[Transfusion permitted to achieve this value\]
• Prothrombin time (PT)/ International normalized ratio (INR)
• NOTE: Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation. ≤ 2.3 or PT ≤ 6 seconds above control.
• RENAL

You may not qualify if:

• Patients who are concurrently enrolled in another clinical study unless it is an observational (non- interventional) clinical study or the follow-up period of an interventional study.
• Patients who are receiving any other investigational agents within 28 days of registration.
• Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y90, 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 institution of supportive care) to any unknown allergens or any components of the systemic therapy
• Patients must not have had prior treatment any PDL1 or PD-1 antagonists
• Patients who have known additional malignancy that progressed or required treatment within the last 3 years. Exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years.
• Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded. These include but are not limited to patients with a history of: immune related neurologic disease
• multiple sclerosis
• autoimmune (demyelinating) neuropathy NU22I07 10.25.22 initial 19
• Guillain-Barre syndrome
• myasthenia gravis
• systemic autoimmune disease such as SLE
• connective tissue diseases
• scleroderma
• inflammatory bowel disease (IBD)

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumab; Bevacizumab; Yttrium-90

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Aparna Kalyan, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 17, 2022
• Study Start: November 30, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)