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

Study Overview
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Brief Summary
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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
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Liver Cancer, Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: LT
* Drug: ADV-TK
* Drug: ganciclovir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LT+ADV-TK<br>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<br>* Orthotopic LT<br>* Other names: liver transplantation;Drug: ADV-TK<br> <br> * Other names: adenovirus-thymidine kinase;Drug: ganciclovir<br> <br> |
| Active Comparator: LT<br>Orthotopic liver transplantation | Procedure: LT<br>* Orthotopic LT<br>* Other names: liver transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | up to 3-year | 
| Recurrence-free survival rate |  | up to 3-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase, gene therapy