p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).

Detailed Description
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It was found in the treatment of HCC using p53 gene therapy that the concurrent diabetes was controlled as well. The objectives of this study are to investigate both anti-diabetic and anti-tumor role of p53 gene therapy. This is an open-labeled, randomized, active-controlled phase 2 study. p53 will be injected via the artery, which supplies blood for the tumor nodules. The study endpoints for anti-diabetic role are fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (A1C) at 30 days after the start of treatment; and for antitumor effect are progression-free survival and overall survival.

Official Title
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A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

Conditions
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HCC, Diabetes

Intervention / Treatment
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* Drug: p53 gene therapy
* Drug: Trans-catheter embolization


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 therapy<br>Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month | Drug: p53 gene therapy<br>* Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month<br>* Other names: recombinant adenoviral human p53 gene therapy;Drug: Trans-catheter embolization<br>* Trans-catheter embolization alone<br>|
| Active Comparator: Trans-catheter embolization<br>Trans-catheter embolization (TAE) will be given once per month | Drug: Trans-catheter embolization<br>* Trans-catheter embolization alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose (FPG) | In 60 days after starting study treatment | from starting treatment until 60 days | 
| glycosylated hemoglobin (A1C) | In 60 days after starting study treatment | from starting treatment until 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | overall survival will be follow up to 2 years. Time to an event (death), or censored status (lost of follow up, withdrawal from the study, or still alive on 2 years) will be recorded. OS will be estimated using Kaplan-Meier method. | 2 years | 
| progression free survival (PFS) | PFS will be follow up to 2 years. Time to an event (progression or death) or censored status (lost of follow up, withdrawal from the study, or still alive and no progression on 2 years). Assessment of progression will follow RECIST standard Version 1.1. PFS will be estimated using Kaplan-Meier method. | 2 years | 
| postprandial glucose (PPG) | from starting treatment until 60 days treatment | from starting treatment until 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concurrent