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Clinical Trial Summary

This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy alone in treating patients with liver cancer that cannot be removed by surgery (unresectable) or has spread to other places in 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 alone.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate progression-free survival (PFS), defined as time to progressive disease or death due to any cause as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. SECONDARY OBJECTIVES: I. To evaluate objective response (OR), defined as a complete or partial response as determined by the investigator according to RECIST v1.1. II. To evaluate overall response (OS), and disease control rate as determined by the investigator using RECIST v1.1. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1, atezolizumab IV over 30-60 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV on days 1 and 8. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive gemcitabine IV over 30 minutes and cisplatin IV on days 1 and 8. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05211323
Study type Interventional
Source National Cancer Institute (NCI)
Status Recruiting
Phase Phase 2
Start date February 11, 2022
Completion date January 31, 2025

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