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NCT02072486 · ClinicalTrials.gov registry record · NA
Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A NA study of Advanced Adult Hepatocellular Carcinoma and Stage IIIA Hepatocellular Carcinoma, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02072486: Completed NA study of Advanced Adult Hepatocellular Carcinoma and Stage IIIA Hepatocellular Carcinoma, sponsored by Roswell Park Cancer Institute.
NCT02072486 is a NA study of Advanced Adult Hepatocellular Carcinoma and Stage IIIA Hepatocellular Carcinoma that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 30 participants, above the 27-participant average among 3 other Advanced Adult Hepatocellular Carcinoma trials with a reported enrollment target (11% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02072486, a NA study of Advanced Adult Hepatocellular Carcinoma and Stage IIIA Hepatocellular Carcinoma, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial studies sorafenib tosylate in treating patients with liver cancer that cannot be removed by surgery. Sorafenib tosylate may block some of the enzymes needed for tumor cell growth. Blocking these enzymes may also help the immune system work better. Granzyme B is a biomarker that can be used to measure how well the immune system is working. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. Studying granzyme B levels in patients receiving sorafenib tosylate may help doctors learn more about the effects of sorafenib tosylate on the immune system and may help to predict how well sorafenib tosylate will work in treating patients with liver cancer.
Primary Outcome
The pGrzB hazard ratio (per 10 percentage point increase) and the associated 95% confidence interval will be estimated using a Cox PH model. Whether pGrzB measurements vary by presence of grade 3+ adverse events (AEs) will be assessed using permutation independent sample t-tests. Descriptive statistics include the pGrzB mean, standard deviations and ranges within AE or patient characteristics.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Sorafenib Tosylate
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-11-18 |
| Est. Completion | 2020-07-19 |
| Phase | NA |
What the finished NCT02072486 record still lists
NCT02072486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, above the 27-participant average among 3 other Advanced Adult Hepatocellular Carcinoma trials with a reported enrollment target (11% higher).
The record links to 9 conditions, with Advanced Adult Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02072486 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02072486 about?
NCT02072486 is a clinical study titled "Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery". This clinical trial studies sorafenib tosylate in treating patients with liver cancer that cannot be removed by surgery. Sorafenib tosylate may block some of the enzymes needed for tumor cell growth. Blocking these enzymes may also help the immune system work better. Granzyme B is a biomarker that c...
What is the current status of trial NCT02072486?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2013-11-18. Estimated completion is 2020-07-19.
What conditions does trial NCT02072486 study?
This clinical trial studies the following conditions: Advanced Adult Hepatocellular Carcinoma, Stage IIIA Hepatocellular Carcinoma, Stage IIIB Hepatocellular Carcinoma, Stage IIIC Hepatocellular Carcinoma, Stage IVA Hepatocellular Carcinoma.
What interventions are being tested in trial NCT02072486?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT02072486?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02072486 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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