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

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01125020
• Other study ID #: 2008BAI60B03
• 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

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Transplantation
• Recurrence
• Survival
• Tumor Recurrence and Metastasis

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