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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01125020
Other study ID # 2008BAI60B03
Secondary ID
Status Recruiting
Phase N/A
First received May 17, 2010
Last updated May 17, 2010
Start date December 2008
Est. completion date December 2010

Study information

Verified date May 2010
Source Shanghai Jiao Tong University School of Medicine
Contact Jun-Yi Wu, MM
Phone 0086-021-63240090
Email wjy8541@126.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
China Shanghai First People's Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Dudek K, Kornasiewicz O, Remiszewski P, Kobryn 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary tumor recurrence and metastasis 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 within the first year after liver transplantation No
Secondary Postoperative survival Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death. within the first year after liver transplantation Yes
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