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

NCT02202564 | Completed Phase 2

• 1 other identifier: LT-02
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Cancer; Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; liver transplantation; adenovirus-thymidine kinase; gene therapy

Outcome Measures

Primary Outcomes (2)

• Overall survival rate

  up to 3-year

• Recurrence-free survival rate

  up to 3-year

Study Arms (2)

LT+ADV-TK

EXPERIMENTAL

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; Drug: ADV-TK; Drug: ganciclovir

LT

ACTIVE COMPARATOR

Orthotopic liver transplantation

Procedure: LT

Interventions

LT PROCEDURE

Orthotopic LT

Also known as: liver transplantation

LT; LT+ADV-TK

ADV-TK DRUG

Also known as: adenovirus-thymidine kinase

LT+ADV-TK

ganciclovir DRUG

LT+ADV-TK

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ～70 years of age (Male and Female).
• Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
• No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
• Provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Beijing YouAn Hospital: collaborator

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Liver Transplantation; Ganciclovir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ding Ma, M.D.

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Laboratory of Tumor invasion and metastasis

Study Record Dates

• First Submitted: July 26, 2014
• First Posted: July 29, 2014
• Study Start: October 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: August 1, 2013
• Last Updated: July 29, 2014

Record last verified: 2014-07