Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202564
• Other study ID #: LT-02
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2014
• Last updated: July 28, 2014
• Start date: October 2006
• Est. completion date: August 2013

Study information

• Verified date: July 2014
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18~70 years of age (Male and Female).

• Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation

• Patients who had unresectable HCC >5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.

• No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.

• Provide written informed consent

Exclusion Criteria:

• Metastasis in lungs and bones

• Invasion in main vescular.

• Contraindications of liver transplantation

• Contraindications of operation of other organ system

• Hypersensitivity to adenovirus, GCV or similar drugs

• Accept clinical trials of other drugs

• Immunological deficit

• Active pregnancy

• Unable or unwilling to sign informed consents

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer

Intervention

Procedure:
• LT
Orthotopic LT

Drug:
• ADV-TK

• ganciclovir

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Beijing YouAn Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		up to 3-year	No
Primary	Recurrence-free survival rate		up to 3-year	No