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Completed

NCT Number: NCT02202564

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

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.

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Key information

Conditions

Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LT

Procedure

Orthotopic LT

Other names: liver transplantation

ADV-TK

Drug

Other names: adenovirus-thymidine kinase

Ganciclovir

Drug

Primary outcomes

  1. Overall survival rate

    Time frame: up to 3-year

  2. Recurrence-free survival rate

    Time frame: up to 3-year

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • Beijing YouAn Hospital

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2013
First posted
Jul 29, 2014
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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