A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer
NCT05211323 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2026-05-13
Summary
This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy and atezolizumab in treating patients with liver cancer that cannot be removed by surgery (unresectable) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). 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. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bevacizumab and atezolizumab with chemotherapy may kill more tumor cells in patients liver cancer than chemotherapy and atezolizumab.
Conditions
- Combined Hepatocellular Carcinoma and Cholangiocarcinoma
- Stage III Liver Cancer
- Stage IV Liver Cancer
Interventions
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Biospecimen Collection
Undergo blood specimen collection
- DRUG
-
Given IV
- PROCEDURE
-
Computed Tomography
Undergo CT
- PROCEDURE
-
Conventional Magnetic Resonance Imaging
Undergo MRI
- DRUG
-
Gemcitabine Hydrochloride
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
David Hsieh · ECOG-ACRIN Cancer Research Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-07
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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