p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02561546
• Other study ID #: p53-DB-001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 11, 2015
• Last updated: September 25, 2015
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2015
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: Yuewei Zhang, MD, Ph D
• Email: zhangyuewei1121[@]sina.com
• Is FDA regulated: No
• Health authority: China: SFDA
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Diabetes
• HCC

Intervention

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

Locations

Country	Name	City	State
China	first affiliated hospital in Dalian University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen SiBiono GeneTech Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting plasma glucose (FPG)	In 60 days after starting study treatment	from starting treatment until 60 days	No
Primary	glycosylated hemoglobin (A1C)	In 60 days after starting study treatment	from starting treatment until 60 days	No
Secondary	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	No
Secondary	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	No
Secondary	postprandial glucose (PPG)	from starting treatment until 60 days treatment	from starting treatment until 60 days	No