Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
NCT05168163 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2025-09-16
Summary
This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). 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 and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.
Conditions
- Locally Advanced Hepatocellular Carcinoma
- Metastatic Hepatocellular Carcinoma
- Stage III Hepatocellular Carcinoma AJCC v8
- Stage IIIA Hepatocellular Carcinoma AJCC v8
- Stage IIIB Hepatocellular Carcinoma AJCC v8
- Stage IV Hepatocellular Carcinoma AJCC v8
- Stage IVA Hepatocellular Carcinoma AJCC v8
- Stage IVB Hepatocellular Carcinoma AJCC v8
- Unresectable Hepatocellular Carcinoma
Interventions
- BIOLOGICAL
-
Given IV
- DRUG
-
Given PO
- DRUG
-
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Genentech, Inc.
collaborator INDUSTRY -
Academic and Community Cancer Research United
lead OTHER
Principal Investigators
-
Wen Wee Ma · Academic and Community Cancer Research United
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-27
- Primary Completion
- 2025-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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