---
title: Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma
nct_id: NCT02509169
overall_status: UNKNOWN
phase: PHASE2
sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
study_type: INTERVENTIONAL
primary_condition: Advanced Hepatocellular Carcinoma (HCC)
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02509169.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02509169"
ct_last_update_post_date: 2015-07-27
last_seen_at: "2026-05-12T07:05:37.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma

**Official Title:** Trans-catheter Arterial p53-gene-embolization Using Gelatin Sponge Particles in Treatment of Patients With Advanced Hepatocellular Carcinoma: A Phase II Study

**NCT ID:** [NCT02509169](https://clinicaltrials.gov/study/NCT02509169)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Shenzhen SiBiono GeneTech Co.,Ltd
- **Conditions:** Advanced Hepatocellular Carcinoma (HCC)
- **Start Date:** 2014-10
- **Completion Date:** 2016-12
- **CT.gov Last Update:** 2015-07-27

## Brief Summary

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).

## Detailed Description

Treatment options for advanced HCC are limited due to patients' poor condition, advanced stage, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) is a safe locoregional treatment for advanced HCC and p53 gene has multiple anticancer functions, and both methods do not have immune-inhibitory effects as chemo- or radio-therapy. The objectives of this study are to investigate clinical efficacy and immunoreaction usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **TAE plus p53 gene** (EXPERIMENTAL) — Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
- **TAE** (ACTIVE_COMPARATOR) — Trans-catheter embolization (TAE) will be given once per month

## Interventions

- **TAE plus P53 gene** (DRUG) — Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy
- **TAE** (OTHER) — Trans-catheter embolization

## Primary Outcomes

- **overall survival** _(time frame: 2 years)_ — overall survival will be follow up to 2 years

## Secondary Outcomes

- **immuno-reaction (lymphocyte counts and subgroup ratios)** _(time frame: 3 months)_
- **progression free survival** _(time frame: 2 years)_

## Locations (1)

- first affiliated hospital in Dalian University, Dalian, Liaoning, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.first affiliated hospital in dalian university|dalian|liaoning|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02509169.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02509169*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*