Clinical trial · Interventional
Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC
Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
NCT03313596CI-TRIAL-00036930unknownPhase 3ClinicalTrials.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)
Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADV-Tk | Drug | — | UNRESOLVED |
| LT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LT-only
- description
- patients received orthotopic LT and subsequent immunosuppression therapy
- interventionNames
- Procedure: LT
- type
- EXPERIMENTAL
- label
- LT+ADV-TK
- description
- ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy
- interventionNames
- Drug: ADV-Tk
- Procedure: LT
Primary outcomes (1)
- measure
- Progression-free survival, PFS
- timeFrame
- 2-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 18 - 65 years of age (Male and Female). * Clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation. * Patients who had unresectable HCC with single tumor diameter \> 5 cm and ≤ 10cm; or numbers of multiple tumors \>3 and ≤ 5, and the total length of foci diameter ≤ 15 cm. * Serum AFP ≤ 10000 ng/ml before liver transplantation. * Child-pugh A-B. * No metastasis in extrahepatic main vescular and extrahepatic lymph node detected during the operation and no metastasis of other organs. * Provide written informed consent before screening. Exclusion Criteria: * Metastasis in extrahepatic organs. * HCC with Invasion in extrahepatic main vescular and extrahepatic organs. * Contraindications of operation of other organ system. * Hypersensitivity to adenovirus, GCV or similar drugs. * Serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%). * Plan to accept clinical trials of other antitumor drugs. * Immunological deficit. * HBsAg(+) and HBcAb(+) donor. * Unsuitable participate assessed by investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.