p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

NCT ID: NCT02561546

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

HCC; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAE plus p53 gene therapy

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

Group Type: EXPERIMENTAL

p53 gene therapy

Intervention Type: DRUG

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

Trans-catheter embolization

Intervention Type: DRUG

Trans-catheter embolization alone

Trans-catheter embolization

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

Group Type: ACTIVE_COMPARATOR

Trans-catheter embolization

Intervention Type: DRUG

Trans-catheter embolization alone

Interventions

p53 gene therapy

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

Intervention Type: DRUG

Trans-catheter embolization

Trans-catheter embolization alone

Intervention Type: DRUG

Other Intervention Names

recombinant adenoviral human p53 gene therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen SiBiono GeneTech Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

first affiliated hospital in Dalian University

Dalian, Liaoning, China

Countries

China

Central Contacts

Yuewei Zhang, MD, Ph D

Role: CONTACT

zhangyuewei1121@sina.com

Gui Gao, MD, Ph D

Role: CONTACT

scottgao1110@gmail.com

Facility Contacts

Yuewei Zhang, MD, Ph D

Role: primary

zhangyuewei1121@sina.com

Other Identifiers

p53-DB-001

Identifier Type: -

Identifier Source: org_study_id