p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02561546

Enrollment

Registered

2015-09-28

Start date

2015-12-31

Completion date

2017-12-31

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, HCC

Keywords

concurrent

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.

Interventions

DRUGp53 gene therapy

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

DRUGTrans-catheter embolization

Trans-catheter embolization alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
fasting plasma glucose (FPG)	from starting treatment until 60 days	In 60 days after starting study treatment
glycosylated hemoglobin (A1C)	from starting treatment until 60 days	In 60 days after starting study treatment

Secondary

Measure	Time frame	Description
overall survival (OS)	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.
progression free survival (PFS)	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.
postprandial glucose (PPG)	from starting treatment until 60 days	from starting treatment until 60 days treatment

Countries

China

Contacts

Primary ContactYuewei Zhang, MD, Ph D

zhangyuewei1121@sina.com

Backup ContactGui Gao, MD, Ph D

scottgao1110@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026