p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

September 25, 2015 updated by: Shenzhen SiBiono GeneTech Co.,Ltd

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting plasma glucose (FPG)
Time Frame: from starting treatment until 60 days
In 60 days after starting study treatment
from starting treatment until 60 days
glycosylated hemoglobin (A1C)
Time Frame: from starting treatment until 60 days
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)
Time Frame: 2 years
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)
Time Frame: 2 years
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)
Time Frame: from starting treatment until 60 days
from starting treatment until 60 days treatment
from starting treatment until 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p53-DB-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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