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

Roswell Park Comprehensive Cancer Center

Status

Completed

Conditions

Stage III Childhood Hepatocellular Carcinoma

Advanced Adult Hepatocellular Carcinoma

Stage IVA Hepatocellular Carcinoma

Stage IIIA Hepatocellular Carcinoma

Stage IV Childhood Hepatocellular Carcinoma

Stage IVB Hepatocellular Carcinoma

Localized Non-Resectable Adult Hepatocellular Carcinoma

Stage IIIC Hepatocellular Carcinoma

Stage IIIB Hepatocellular Carcinoma

Treatments

Drug: Sorafenib Tosylate

Other: Laboratory Biomarker Analysis

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02072486

I 238913 (Other Identifier)

NCI-2014-00180 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable hepatocellular carcinoma (HCC) who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made; radiographic diagnosis needs typical findings of HCC by a radiographic method, i.e. on multi-dimensional dynamic computed tomography (CT), CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or magnetic resonance imaging (MRI)
Patients must have a life expectancy of at least 8 weeks
Patients must not have any evidence of bleeding diathesis or active gastrointestinal bleeding

Exclusion criteria

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or nursing female subjects
Unwilling or unable to follow protocol requirements
Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
Patients who have had prior anti-angiogenic therapy, including but not limited to sorafenib, brivanib, bevacizumab, or sunitinib; prior treatment with liver directed, ablative or surgical therapies will be permitted as long as there is documented progression justifying the need for starting sorafenib therapy
No known contraindications to anti-angiogenics such as severe coronary artery disease, recent myocardial infarction or stroke within 6 months, bleeding peptic ulcer or varices within last 3 months, and any other major illness that may jeopardize study treatment or follow up