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A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082082
Recruitment Status : Completed
First Posted : April 30, 2004
Last Update Posted : January 15, 2008
Information provided by:
SciClone Pharmaceuticals

Brief Summary:
The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Thymalfasin (thymosin alpha-1) Procedure: Trans arterial chemoembolization (TACE) Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent.
  • Diagnosis of HCC by:

    1. Presence of HCC on biopsy (core biopsy), or, if biopsy is strongly contra-indicated due to safety or patient-related concerns, then the diagnosis of HCC can be determined by:
    2. A new hepatic defect on imaging with an AFP > 1000 ng/ml, or
    3. A new hepatic defect on ultrasound or CT with an AFP < 1000 ng/ml when one of the following is present:

      1. At least two additional imaging techniques show signs characteristic of HCC, or
      2. The new hepatic defect has doubled in diameter over time, or
      3. The AFP has progressively risen to > 200 ng/ml and triples the mean baseline.
  • HCC must be unresectable and non-transplantable.
  • Hematocrit > 30%, platelet count >= 50,000 per microliter, WBC > 2.0 x 109/L, and polymorphonuclear white cell count >= 1.0 x 109/L.
  • Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/dl.
  • If the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal.

Exclusion Criteria:

  • Concomitant chronic use of any drug known to be hepatotoxic, or of any immunosuppressive drug (Use of oral contraceptives will not exclude an otherwise eligible patient).
  • Presence of main portal vein thrombosis or hepatic artery malformation.
  • HCC amenable to treatment by surgical resection or hepatic transplantation.
  • HIV infection diagnosed by HIV seropositivity and confirmed by Western blot.
  • Concomitant or prior history of malignancy other than HCC within the last 10 years, except for curatively treated skin cancer or surgically cured in situ carcinoma of the cervix.
  • Active infectious process that is not of a self-limiting nature. TB and AIDS are examples of infectious processes that are not of a self-limiting nature.
  • Pregnancy as documented by a urine pregnancy test. Women with reproductive potential must agree to practice an adequate method of birth control for the duration of the study.
  • Alcohol or intravenous drug abuse within the previous 1 year.
  • Previous treatment with thymalfasin.
  • Patients with known hypersensitivity to iodine.
  • Simultaneous participation in another investigational drug study, or participation in any clinical trial involving investigational drugs within 30 days of study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082082

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United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
SciClone Pharmaceuticals
Layout table for additonal information Identifier: NCT00082082    
Other Study ID Numbers: Ta1-HCC-2K1001
First Posted: April 30, 2004    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs