Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
SciClone Pharmaceuticals |
---|---|
Information provided by: | SciClone Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00082082 |
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 | Intervention | Phase |
---|---|---|
Carcinoma, Hepatocellular |
Drug: Thymalfasin (thymosin alpha-1) Procedure: Trans arterial chemoembolization (TACE) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of HCC by:
A new hepatic defect on ultrasound or CT with an AFP < 1000 ng/ml when one of the following is present:
Exclusion Criteria:
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 |
Study ID Numbers: | Ta1-HCC-2K1001 |
Study First Received: | April 28, 2004 |
Last Updated: | January 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00082082 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Liver Diseases Digestive System Neoplasms Immunologic Factors Carcinoma, Hepatocellular Adjuvants, Immunologic Carcinoma Liver Neoplasms |
Digestive System Diseases Thymalfasin Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Immunologic Factors Carcinoma, Hepatocellular Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |
Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Thymalfasin Therapeutic Uses Adenocarcinoma Neoplasms, Glandular and Epithelial |