Hepatocellular Carcinoma, Liver Cancer
Conditions
Keywords
hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase, gene therapy
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.
Sponsors
Beijing YouAn Hospital
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rate | up to 3-year |
| Recurrence-free survival rate | up to 3-year |
Outcome results
None listed