Yttrium Y 90 Glass Microspheres, Atezolizumab, and Cabozantinib for the Treatment of Unresectable or Locally Advanced Hepatocellular Carcinoma

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT05327738
Phase
PHASE2
Status
Withdrawn

Conditions

  • BCLC Stage B Hepatocellular Carcinoma
  • BCLC Stage C Hepatocellular Carcinoma
  • Locally Advanced Hepatocellular Carcinoma
  • Recurrent Hepatocellular Carcinoma
  • Unresectable Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — BIOLOGICAL
    Given IV
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Cabozantinib S-malate — DRUG
    Given PO
  • Yttrium Y 90 Glass Microspheres — RADIATION
    Given intra-arterially

Study Details

This phase II trial tests whether yttrium Y 90 glass microspheres, atezolizumab, and cabozantinib work to shrink tumors in patients with liver cancer (hepatocellular carcinoma) that cannot be removed by surgery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Yttrium Y 90 glass microspheres consists of millions of microscopic glass spheres containing yttrium-90, a radioactive substance. Yttrium Y 90 glass microspheres are delivered to the tumor in the liver through a catheter in an artery. Radiation from the Yttrium-90 helps treat the tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The combination of yttrium Y 90 glass microspheres, atezolizumab, and cabozantinib may kill more tumor cells.

Key Dates

Start date
Dec 10, 2022
Status verified
Dec 2022
Primary completion
Dec 4, 2027
Completion
Dec 4, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (atezolizumab, Y-90, cabozantinib)
    CYCLE 1: Patients receive atezolizumab IV over 60 minutes on day 1. Within 14 days, patients receive Y-90 intra-arterially. CYCLES 2+: Patients receive atezolizumab IV over 60 minutes on day 1 and cabozantinib PO QD on days 1-21. Treatment repeats every 21 days for a total of 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit may continue receiving atezolizumab and cabozantinib beyond cycle 12 at the discretion of the PI.

Primary Outcome Measure

Proportion of progression-free participants [ Time Frame: From first dose of study intervention up to 6 months from first dose of study intervention ]

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