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

NCT05327738 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-12-14

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

BIOLOGICAL

Atezolizumab

Given IV

PROCEDURE

Biopsy

Undergo biopsy

DRUG

Cabozantinib S-malate

Given PO

RADIATION

Yttrium Y 90 Glass Microspheres

Given intra-arterially

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Adel Kardosh, M.D., Ph.D. · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-10
Primary Completion
2027-12-04
Completion
2027-12-04
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327738 on ClinicalTrials.gov