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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02561546
Other study ID # p53-DB-001
Secondary ID
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


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
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