Clinical trial · Interventional
Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
NCT02202564CI-TRIAL-00015245completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADV-TK | Drug | — | UNRESOLVED |
| ganciclovir | Drug | — | UNRESOLVED |
| LT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LT+ADV-TK
- description
- 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.
- interventionNames
- Procedure: LT
- Drug: ADV-TK
- Drug: ganciclovir
- type
- ACTIVE_COMPARATOR
- label
- LT
- description
- Orthotopic liver transplantation
- interventionNames
- Procedure: LT
Primary outcomes (2)
- measure
- Overall survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.