Clinical trial · Interventional
Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma
Trans-catheter Arterial p53-gene-embolization Using Gelatin Sponge Particles in Treatment of Patients With Advanced Hepatocellular Carcinoma: A Phase II Study
NCT02509169CI-TRIAL-00018651unknownPhase 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)
An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).
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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAE | Other | — | UNRESOLVED |
| TAE plus P53 gene | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAE plus p53 gene
- description
- Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
- interventionNames
- Drug: TAE plus P53 gene
- type
- ACTIVE_COMPARATOR
- label
- TAE
- description
- Trans-catheter embolization (TAE) will be given once per month
- interventionNames
- Other: TAE
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * histopathologically diagnosed unresectable HCC * over 18 years old * with an Eastern Cooperative Oncology Group (ECOG) score of 0-2 * with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C * with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function * signed the informed consent form. Exclusion Criteria: * hypersensitive to study drug * With an abnormal coagulation condition or bleeding disorder * infections * with serious conditions which prevent using the study treatment * pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.