HCCPhase 2NCT02561546
p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
A Phase 2 study testing p53 gene therapy and Trans-catheter embolization in people with HCC and Diabetes, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- p53 gene therapy and Trans-catheter embolization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Yuewei Zhang, MD, Ph D contact
Gui Gao, MD, Ph D contact
China1 site
first affiliated hospital in Dalian University
Dalian, Liaoning
Yuewei Zhang, MD, Ph D, zhangyuewei1121@sina.com
About this study
Official title: A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).
Read the 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.
- Being tested
- p53 gene therapy, Trans-catheter embolization
- Keywords
- concurrent
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p53 gene therapyDrug
Also called recombinant adenoviral human p53 gene therapy
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Trans-catheter embolizationDrug
Trans-catheter embolization alone
| Study group | Role | What they receive |
|---|---|---|
| TAE plus p53 gene therapy | Experimental | Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month Receives: Drug: p53 gene therapy; Drug: Trans-catheter embolization |
| Trans-catheter embolization | Active comparator | Trans-catheter embolization (TAE) will be given once per month Receives: Drug: Trans-catheter embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting plasma glucose (FPG)
In 60 days after starting study treatment
Measured: from starting treatment until 60 days
glycosylated hemoglobin (A1C)
In 60 days after starting study treatment
Measured: from starting treatment until 60 days
Secondary outcomes (3)
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.
Measured: 2 years
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.
Measured: 2 years
postprandial glucose (PPG)
from starting treatment until 60 days treatment
Measured: from starting treatment until 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561546
- Sponsor's protocol ID
- p53-DB-001
- Status last verified
- Jul 2015
- First submitted
- 11 Sep 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02561546
- Acronym / sponsor ID
- p53-DB-001
- Keywords
- concurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAE plus p53 gene therapy | Experimental | Drug: p53 gene therapy, Drug: Trans-catheter embolizationTrans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month |
| Trans-catheter embolization | Active comparator | Drug: Trans-catheter embolizationTrans-catheter embolization (TAE) will be given once per month |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| p53 gene therapyAlso: recombinant adenoviral human p53 gene therapyTrans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month | Drug | TAE plus p53 gene therapy |
| Trans-catheter embolizationTrans-catheter embolization alone | Drug | TAE plus p53 gene therapy, Trans-catheter embolization |
Primary outcome
fasting plasma glucose (FPG)
Time frame: from starting treatment until 60 days
In 60 days after starting study treatment
glycosylated hemoglobin (A1C)
Time frame: from starting treatment until 60 days
In 60 days after starting study treatment
3 secondary outcomes
overall survival (OS)
Time frame: 2 years
progression free survival (PFS)
Time frame: 2 years
postprandial glucose (PPG)
Time frame: from starting treatment until 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuewei Zhang, MD, Ph D contact
Gui Gao, MD, Ph D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing p53 gene therapy and Trans-catheter embolization in people with HCC and Diabetes, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuewei Zhang, MD, Ph D (zhangyuewei1121@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting plasma glucose (FPG) (time frame: from starting treatment until 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.