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

Shanghai Jiao Tong University School of Medicine1 site in 1 country150 target enrollmentDecember 2008

ConditionsLiver Transplantation Hepatocellular Carcinoma Tumor Recurrence and Metastasis Survival Adjuvant Chemotherapy

Interventionsgemcitabine and oxaliplatin doxorubicin, 5-Fu and cisplatin

Drugsgemcitabine and oxaliplatin doxorubicin, 5-Fu and cisplatin

Overview

Phase: N/A
Intervention: gemcitabine and oxaliplatin
Conditions: Liver Transplantation
Sponsor: Shanghai Jiao Tong University School of Medicine
Enrollment: 150
Locations: 1
Primary Endpoint: tumor recurrence and metastasis
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

December 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

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

Arms & Interventions

gemcitabine and oxaliplatin

Intervention: gemcitabine and oxaliplatin

doxorubicin, 5-Fu and cisplatin

Intervention: doxorubicin, 5-Fu and cisplatin

Outcomes

Primary Outcomes

tumor recurrence and metastasis

Time Frame: 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