Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Hepatocellular Carcinoma (HCC)

Intervention / Treatment
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* Drug: TAE plus P53 gene
* Other: TAE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAE plus p53 gene<br>Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month | Drug: TAE plus P53 gene<br>* Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy<br>|
| Active Comparator: TAE<br>Trans-catheter embolization (TAE) will be given once per month | Other: TAE<br>* Trans-catheter embolization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival will be follow up to 2 years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immuno-reaction (lymphocyte counts and subgroup ratios) | The immune reaction after study treatment will be assessed every one week until 3 months after the first treatment | 3 months | 
| progression free survival |  | 2 years |