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p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02561546
Recruitment Status : Unknown
Verified July 2015 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd

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).

Condition or disease Intervention/treatment Phase
HCC Diabetes Drug: p53 gene therapy Drug: Trans-catheter embolization Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
Study Start Date : December 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAE plus p53 gene therapy
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Drug: p53 gene therapy
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Other Name: recombinant adenoviral human p53 gene therapy

Drug: Trans-catheter embolization
Trans-catheter embolization alone

Active Comparator: Trans-catheter embolization
Trans-catheter embolization (TAE) will be given once per month
Drug: Trans-catheter embolization
Trans-catheter embolization alone




Primary Outcome Measures :
  1. fasting plasma glucose (FPG) [ Time Frame: from starting treatment until 60 days ]
    In 60 days after starting study treatment

  2. glycosylated hemoglobin (A1C) [ Time Frame: from starting treatment until 60 days ]
    In 60 days after starting study treatment


Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 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.

  2. progression free survival (PFS) [ Time Frame: 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.

  3. postprandial glucose (PPG) [ Time Frame: from starting treatment until 60 days ]
    from starting treatment until 60 days treatment



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561546


Contacts
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Contact: Yuewei Zhang, MD, Ph D zhangyuewei1121@sina.com
Contact: Gui Gao, MD, Ph D scottgao1110@gmail.com

Locations
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China, Liaoning
first affiliated hospital in Dalian University Not yet recruiting
Dalian, Liaoning, China
Contact: Yuewei Zhang, MD, Ph D       zhangyuewei1121@sina.com   
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd

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Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier: NCT02561546     History of Changes
Other Study ID Numbers: p53-DB-001
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: July 2015
Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
concurrent
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases