p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

SiBiono

Status and phase: Unknown; Phase 2

Conditions: Diabetes; HCC

Treatments: Drug: Trans-catheter embolization; Drug: p53 gene therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02561546

p53-DB-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

TAE plus p53 gene therapy

Experimental group

Description:

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

Treatment:

Drug: Trans-catheter embolization

Drug: p53 gene therapy

Trans-catheter embolization

Active Comparator group

Description:

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

Treatment:

Drug: Trans-catheter embolization