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p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

Primary Purpose

HCC, Diabetes

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
p53 gene therapy
Trans-catheter embolization
Sponsored by
Shenzhen SiBiono GeneTech Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCC focused on measuring concurrent

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • first affiliated hospital in Dalian University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAE plus p53 gene therapy

Trans-catheter embolization

Arm Description

Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month

Trans-catheter embolization (TAE) will be given once per month

Outcomes

Primary Outcome Measures

fasting plasma glucose (FPG)
In 60 days after starting study treatment
glycosylated hemoglobin (A1C)
In 60 days after starting study treatment

Secondary Outcome Measures

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.
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.
postprandial glucose (PPG)
from starting treatment until 60 days treatment

Full Information

First Posted
September 11, 2015
Last Updated
September 25, 2015
Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02561546
Brief Title
p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
Official Title
A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC, Diabetes
Keywords
concurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAE plus p53 gene therapy
Arm Type
Experimental
Arm Description
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Arm Title
Trans-catheter embolization
Arm Type
Active Comparator
Arm Description
Trans-catheter embolization (TAE) will be given once per month
Intervention Type
Drug
Intervention Name(s)
p53 gene therapy
Other Intervention Name(s)
recombinant adenoviral human p53 gene therapy
Intervention Description
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Intervention Type
Drug
Intervention Name(s)
Trans-catheter embolization
Intervention Description
Trans-catheter embolization alone
Primary Outcome Measure Information:
Title
fasting plasma glucose (FPG)
Description
In 60 days after starting study treatment
Time Frame
from starting treatment until 60 days
Title
glycosylated hemoglobin (A1C)
Description
In 60 days after starting study treatment
Time Frame
from starting treatment until 60 days
Secondary Outcome Measure Information:
Title
overall survival (OS)
Description
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.
Time Frame
2 years
Title
progression free survival (PFS)
Description
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.
Time Frame
2 years
Title
postprandial glucose (PPG)
Description
from starting treatment until 60 days treatment
Time Frame
from starting treatment until 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuewei Zhang, MD, Ph D
Email
zhangyuewei1121@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gui Gao, MD, Ph D
Email
scottgao1110@gmail.com
Facility Information:
Facility Name
first affiliated hospital in Dalian University
City
Dalian
State/Province
Liaoning
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuewei Zhang, MD, Ph D
Email
zhangyuewei1121@sina.com

12. IPD Sharing Statement

Learn more about this trial

p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

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