Status:
COMPLETED
Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Huazhong University of Science and Technology
Collaborating Sponsors:
Beijing YouAn Hospital
Conditions:
Liver Cancer
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 trans...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT02202564
Start Date
October 1 2006
End Date
August 1 2013
Last Update
July 29 2014
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