N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Liver Transplantation, Hepatocellular Carcinoma, Tumor Recurrence and Metastasis, Survival, Adjuvant Chemotherapy
Both
Liver Transplantation, Hepatocellular Carcinoma, Tumor Recurrence and Metastasis, Survival, Adjuvant Chemotherapy
Trial Information
Inclusion Criteria:
- All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and
May 2010 are potentially eligible for enrollment.
Exclusion Criteria:
- Age less than 18 years
- Treatment with other postoperative adjuvant chemotherapy
- Survival is less than 3 months after liver transplantation
- Inability to provide written informed consent prior to study entry
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
tumor recurrence and metastasis
Outcome Description:
Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy
Outcome Time Frame:
within the first year after liver transplantation
Safety Issue:
No
Principal Investigator
Zhi-Hai Peng, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Shanghai First People's Hospital
Authority:
China: Ethics Committee
Study ID:
2008BAI60B03
NCT ID:
NCT01125020
Start Date:
December 2008
Completion Date:
December 2010
Related Keywords:
- Liver Transplantation
- Hepatocellular Carcinoma
- Tumor Recurrence and Metastasis
- Survival
- Adjuvant Chemotherapy
- Carcinoma
- Neoplasm Metastasis
- Recurrence
- Carcinoma, Hepatocellular
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