Advanced Hepatocellular Carcinoma (HCC)Phase 2NCT02509169
Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma
A Phase 2 study testing TAE plus P53 gene and TAE in people with Advanced Hepatocellular Carcinoma (HCC), run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
Trial summary
An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- TAE plus P53 gene and TAE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2016
- 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 and Ph D contact
Gui Gao, MD, Ph D contact
China1 site, 1 recruiting
- Recruiting
first affiliated hospital in Dalian University
Dalian, Liaoning
Yuewei Zhang, MD, Ph D, zhangyuewei1121@sina.com
About this study
Official title: Trans-catheter Arterial p53-gene-embolization Using Gelatin Sponge Particles in Treatment of Patients With Advanced Hepatocellular Carcinoma: A Phase II Study
An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).
Read the detailed description
Treatment options for advanced HCC are limited due to patients' poor condition, advanced stage, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) is a safe locoregional treatment for advanced HCC and p53 gene has multiple anticancer functions, and both methods do not have immune-inhibitory effects as chemo- or radio-therapy. The objectives of this study are to investigate clinical efficacy and immunoreaction usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Being tested
- TAE plus P53 gene, TAE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAE plus P53 geneDrug
Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy
TAEOther
Trans-catheter embolization
| Study group | Role | What they receive |
|---|---|---|
| TAE plus p53 gene | Experimental | Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month Receives: Drug: TAE plus P53 gene |
| TAE | Active comparator | Trans-catheter embolization (TAE) will be given once per month Receives: Other: TAE |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival will be follow up to 2 years
Measured: 2 years
Secondary outcomes (2)
immuno-reaction (lymphocyte counts and subgroup ratios)
The immune reaction after study treatment will be assessed every one week until 3 months after the first treatment
Measured: 3 months
progression free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies 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
- 60 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
- NCT02509169
- Sponsor's protocol ID
- TCAp53-110
- Status last verified
- Jul 2015
- First submitted
- 19 Jul 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-catheter Arterial p53-gene-embolization Using Gelatin Sponge Particles in Treatment of Patients With Advanced Hepatocellular Carcinoma: A Phase II Study
- ClinicalTrials.gov ID
- NCT02509169
- Acronym / sponsor ID
- TCAp53-110
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Jul 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, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).
Detailed description
Treatment options for advanced HCC are limited due to patients' poor condition, advanced stage, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) is a safe locoregional treatment for advanced HCC and p53 gene has multiple anticancer functions, and both methods do not have immune-inhibitory effects as chemo- or radio-therapy. The objectives of this study are to investigate clinical efficacy and immunoreaction usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.
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 | Experimental | Drug: TAE plus P53 geneTrans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month |
| TAE | Active comparator | Other: TAETrans-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 |
|---|---|---|
| TAE plus P53 geneTrans-catheter embolization combined with recombinant adenoviral human p53 gene therapy | Drug | TAE plus p53 gene |
| TAETrans-catheter embolization | Other | TAE |
Primary outcome
overall survival
Time frame: 2 years
overall survival will be follow up to 2 years
2 secondary outcomes
immuno-reaction (lymphocyte counts and subgroup ratios)
Time frame: 3 months
progression free survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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 and 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 TAE plus P53 gene and TAE in people with Advanced Hepatocellular Carcinoma (HCC), 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 27 Jul 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 and 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?
overall survival (time frame: 2 years). 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 27 Jul 2015.