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
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 28, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 28, 2015
July 1, 2015
1.8 years
September 11, 2015
September 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
fasting plasma glucose (FPG)
In 60 days after starting study treatment
from starting treatment until 60 days
glycosylated hemoglobin (A1C)
In 60 days after starting study treatment
from starting treatment until 60 days
Secondary Outcomes (3)
overall survival (OS)
2 years
progression free survival (PFS)
2 years
postprandial glucose (PPG)
from starting treatment until 60 days
Study Arms (2)
TAE plus p53 gene therapy
EXPERIMENTALTrans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Trans-catheter embolization
ACTIVE COMPARATORTrans-catheter embolization (TAE) will be given once per month
Interventions
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Trans-catheter embolization alone
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
first affiliated hospital in Dalian University
Dalian, Liaoning, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2015
First Posted
September 28, 2015
Study Start
December 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
September 28, 2015
Record last verified: 2015-07