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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05211323
Other study ID # NCI-2022-00151
Secondary ID NCI-2022-00151EA
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 7, 2022
Est. completion date January 31, 2025

Study information

Verified date May 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. The null hypothesis of equality of PFS will be tested using a one-sided alternative favoring the quadruplet arm. The primary comparison will be via a one-sided log rank test. From start of treatment until progression, assessed up to 3 years
Secondary Objective response rate Defined as a complete or partial response as determined by the investigator according to RECIST v1.1. Will be tested using a Fisher's exact test at a one-sided significance level of 0.10. Up to 3 years
Secondary Overall response rate Will be tested using a Fisher's exact test at a one-sided significance level of 0.10. Up to 3 years
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