Hepatitis C Virus Chronic Infection, Hepatocellular Carcinoma
Conditions
Brief summary
CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.
Interventions
BIOLOGICALCP 675,206
Sponsors
Pfizer
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unequivocal diagnosis of HCC * unresectable disease not amenable to locoregional treatment. * a 4-week washout period after sorafenib or any other systemic agent * a 2-month washout period after internal or external radiation * HCV chronic infection * Child-Pugh stage A or B * Measurable disease according to RECIST criteria * ECOG \< 2 * expected survival \> 3 months * Adequate liver, renal and blood functions * ability to sign informed consent
Exclusion criteria
* previous treatment with an anti-CTL-4 agent * serious infections or disease compromising general health status * autoimmune disease that requires therapy * treatment with immunosuppressors * treatment with investigational agents * other neoplasms except skin and bladder superficial tumors * pregnancy or lactation * SNC metastasis * HIV infection * relevant heart disease (NYHA class III or IV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Hepatitis C Virus (HCV) viral load | — |
Countries
Spain
Outcome results
None listed