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Atezolizumab and Bevacizumab in Combination With TACE for Patients With BCLC B HCC

NCT05776875 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-01-15

Study results available
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Summary

There is an unmet need for patients with intermediate stage hepatocellular carcinoma (HCC). It is known that local tumor ablation can increase tumor immunogenicity by releasing tumor associated antigens, potentially increasing the response to immune therapy not just locally, but systemically. In addition, there is now positive data with immune therapy in advanced HCC, there is renewed interest in the combination of local therapy and systemic therapy in Barcelona Clinic Liver Clinic B (BCLC B) patients with systemic therapies other than sorafenib. Based on this data, the investigators plan to examine the atezolizumab and bevacizumab combination with Transarterial Chemoembolization (TACE) in patients with BCLC B HCC.

Conditions

Interventions

DRUG

Atezolizumab Injection

Atezolizumab is a monoclonal antibody medication used to treat urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), hepatocellular carcinoma, and alveolar soft part sarcoma It is a fully humanized, engineered monoclonal antibody of Immunoglobulin G1 (IgG1) isotype against the protein programmed cell death-ligand 1 (PD-L1).

DRUG

Bevacizumab

Bevacizumab, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).

COMBINATION_PRODUCT

Transarterial chemoembolization

Transarterial chemoembolization (TACE) is a local therapy for HCC which induces tumor necrosis.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Stacy Stein, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2024-12-05
Completion
2024-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05776875 on ClinicalTrials.gov