Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

Not Applicable

• Conditions: Liver Transplantation; Hepatocellular Carcinoma; Tumor Recurrence and Metastasis; Survival; Adjuvant Chemotherapy
• Interventions: Drug: doxorubicin, 5-Fu and cisplatin; Drug: gemcitabine and oxaliplatin

• Registration Number: NCT01125020
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-17
• Last Update Submitted: 2010-05-17
• Study First Posted: 2010-05-18
• Last Update Posted: 2010-05-18
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
doxorubicin, 5-Fu and cisplatin	doxorubicin, 5-Fu and cisplatin	-
gemcitabine and oxaliplatin	gemcitabine and oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
tumor recurrence and metastasis	within the first year after liver transplantation	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

Secondary Outcome Measures

Name	Time	Method
Postoperative survival	within the first year after liver transplantation	Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.

Trial Locations

Locations (1)

Shanghai First People's Hospital; 🇨🇳 Shanghai, Shanghai, China