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Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma, Hepatitis C Virus Chronic Infection

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Trial Information

Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)

Safety Issue:

No

Principal Investigator

Jesús Prieto-Valtuena, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Clinica Universidad de Navarra

Authority:

Spain: Spanish Agency of Medicines

Study ID:

CT-2007-01

NCT ID:

NCT01008358

Start Date:

December 2008

Completion Date:

May 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatitis C Virus Chronic Infection
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Carcinoma, Hepatocellular

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