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NCT04145141 · ClinicalTrials.gov record · last posted 2026-08-26

National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer

StatusCompleted
PhaseNot specified
Started2021-07-28
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from the ClinicalTrials.gov record
Background: Primary Liver Cancer is the second most common cause of cancer-related death worldwide. It is the cancer with the fastest rising incidence and mortality in the United States. Researchers want to learn more about liver cancer to help them design better treatments. Objective: To better understand liver cancer. Eligibility: People ages 18 and older who have liver cancer and had or are planning to have immune therapy Design: Participants will be screened with a review of their medical records. They will be asked about their medical history and test results. Participants will come to the NIH Clinical Center. During this visit, their medical records, test results, imaging studies, and tissue samples (if available) will be gathered. Participants will learn the results of a test to see if they have any mutations known to be connected to cancer. They will learn if there are treatment options for them. Participants will give blood, urine, and stool samples or rectal swabs. Participants will not have follow-up visits just for this study. If they join another NIH research study and have visits for this other study, their medical records; test results; and blood, urine, and stool samples may be collected. This will occur about every 3 months. If they have a biopsy or surgery on another study or as part of treatment and there is leftover tissue, researchers would like to collect some of that tissue. Participants will be contacted every 6 months by phone or e-mail. They will be asked about their health. They will provide any medical records, test results, and imaging studies. Participants will be followed on this study for life.

Protocol amendment history 6 changes detected by DataLookout

2026-08-25
notable
Trial completed
2026-08-25
minor
Primary completion moved earlier: 2027-12-31 → 2026-08-06
2026-08-25
minor
Completion moved earlier: 2027-12-31 → 2026-08-06
2026-03-31
notable
Trial status changed: Recruiting → Active, Not Recruiting
2026-03-31
critical
Enrollment reduced: 500 → 132 participants
2026-03-31
minor
Trial sites reduced: 7 → 4 locations
Trial Details
NCT Number NCT04145141
Lead Sponsor National Cancer Institute (NCI)
Conditions Hepatocellular Carcinoma, Liver Cancer, Cholangiocarcinoma
Enrollment 132 participants
Start Date 2021-07-28
Primary Completion 2026-08-06 (estimated)
Study Completion 2026-08-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-26