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

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ClinicalTrials.gov Identifier: NCT02202564
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
Sponsor:
Collaborator:
Beijing YouAn Hospital
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Cancer Hepatocellular Carcinoma Procedure: LT Drug: ADV-TK Drug: ganciclovir Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2006
Actual Primary Completion Date : October 2011
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ganciclovir

Arm Intervention/treatment
Experimental: LT+ADV-TK
Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.
Procedure: LT
Orthotopic LT
Other Name: liver transplantation

Drug: ADV-TK
Other Name: adenovirus-thymidine kinase

Drug: ganciclovir
Active Comparator: LT
Orthotopic liver transplantation
Procedure: LT
Orthotopic LT
Other Name: liver transplantation




Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: up to 3-year ]
  2. Recurrence-free survival rate [ Time Frame: up to 3-year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02202564


Sponsors and Collaborators
Huazhong University of Science and Technology
Beijing YouAn Hospital
Investigators
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Principal Investigator: Ding Ma, M.D. Huazhong University of Science and Technology
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Responsible Party: Ding Ma, Director of the Laboratory of Tumor invasion and metastasis, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02202564    
Other Study ID Numbers: LT-02
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Keywords provided by Ding Ma, Huazhong University of Science and Technology:
hepatocellular carcinoma
liver transplantation
adenovirus-thymidine kinase
gene therapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action