NCT02072486

Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Granzyme B Production as a Biomarker for the Immunomodulatory Activity of Sorafenib in HCC

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether the proportion of cytotoxic T lymphocytes that are producing granzyme B (denoted pGrzB) as measured \~28-35 days after initiation of sorafenib (sorafenib tosylate) therapy correlates with overall survival, defined as the number of months between the start of sorafenib treatment and death from any cause. SECONDARY OBJECTIVES: I. To determine whether higher pGrzB levels will correlate with better sorafenib tolerance, manifested by fewer dose reductions, dose interruptions and adverse events. II. To determine whether improved immune function may also result in greater recognition of hepatitis viral antigens. OUTLINE: Patients receive sorafenib tosylate orally (PO) twice daily (BID). Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed up for 30 days or after the 6 month time point if continuing sorafenib tosylate and then periodically thereafter.

Conditions

• Advanced Adult Hepatocellular Carcinoma
• Localized Non-Resectable Adult Hepatocellular Carcinoma
• Stage III Childhood Hepatocellular Carcinoma
• Stage IIIA Hepatocellular Carcinoma
• Stage IIIB Hepatocellular Carcinoma
• Stage IIIC Hepatocellular Carcinoma
• Stage IV Childhood Hepatocellular Carcinoma
• Stage IVA Hepatocellular Carcinoma
• Stage IVB Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Sorafenib Tosylate	Given PO

Timeline

• Start date: 2013-11-18
• Primary completion: 2019-07-19
• Completion: 2020-07-19
• First posted: 2014-02-26
• Last updated: 2022-07-25

Locations

1 site across 1 country: United States