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

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ClinicalTrials.gov Identifier: NCT01125020
Recruitment Status : Unknown
Verified May 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : May 18, 2010
Last Update Posted : May 18, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Liver Transplantation Hepatocellular Carcinoma Tumor Recurrence and Metastasis Survival Adjuvant Chemotherapy Drug: gemcitabine and oxaliplatin Drug: doxorubicin, 5-Fu and cisplatin

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2008
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: gemcitabine and oxaliplatin Drug: gemcitabine and oxaliplatin
Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.
Active Comparator: doxorubicin, 5-Fu and cisplatin Drug: doxorubicin, 5-Fu and cisplatin
Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Postoperative survival [ Time Frame: within the first year after liver transplantation ]
    Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125020

Contact: Jun-Yi Wu, MM 0086-021-63240090 ext 3136 wjy8541@126.com

China, Shanghai
Shanghai First People's Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Zhi-Hai Peng, MD    0086-021-63240090 ext 3132    pengpzh@hotmail.com   
Principal Investigator: Jun-Wei Fan, MD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Study Chair: Zhi-Hai Peng, MD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
More Information

Responsible Party: Shanghai First People's Hosptial
ClinicalTrials.gov Identifier: NCT01125020     History of Changes
Other Study ID Numbers: 2008BAI60B03
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Liposomal doxorubicin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic