Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
Study Details
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 | Phase |
|---|---|---|
|
N/A |
Study Design
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
- 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
- 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.
Eligibility Criteria
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
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Survival is less than 3 months after liver transplantation
-
Inability to provide written informed consent prior to study entry
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai First People's Hospital | Shanghai | Shanghai | China | 200080 |
Sponsors and Collaborators
- Shanghai Jiao Tong University School of Medicine
- Shanghai Changzheng Hospital
Investigators
- Study Chair: Zhi-Hai Peng, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Dudek K, Kornasiewicz O, Remiszewski P, Kobryń K, Ziarkiewicz-Wróblewska B, Górnicka B, Zieniewicz K, Krawczyk M. Impact of tumor characteristic on the outcome of liver transplantation in patients with hepatocellular carcinoma. Transplant Proc. 2009 Oct;41(8):3135-7. doi: 10.1016/j.transproceed.2009.08.016.
- Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taïeb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90.
- Söderdahl G, Bäckman L, Isoniemi H, Cahlin C, Höckerstedt K, Broomé U, Mäkisalo H, Friman S, Ericzon BG. A prospective, randomized, multi-centre trial of systemic adjuvant chemotherapy versus no additional treatment in liver transplantation for hepatocellular carcinoma. Transpl Int. 2006 Apr;19(4):288-94.
- 2008BAI60B03