A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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).

Official Title
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A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Drug: Thymalfasin (thymosin alpha-1)
* Procedure: Trans arterial chemoembolization (TACE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent. Diagnosis of HCC by: 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: A new hepatic defect on imaging with an AFP > 1000 ng/ml, or A new hepatic defect on ultrasound or CT with an AFP < 1000 ng/ml when one of the following is present: At least two additional imaging techniques show signs characteristic of HCC, or The new hepatic defect has doubled in diameter over time, or 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymalfasin (thymosin alpha-1)|nan|
|Procedure: Trans arterial chemoembolization (TACE)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |