Non-small Cell Lung CancerPhase 2rAd-p53NCT01574729
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
A Phase 2 study testing Surgery combined with rAd-p53 gene therapy and Surgery in people with Non-small Cell Lung Cancer, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
Trial summary
The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Surgery combined with rAd-p53 gene therapy and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- historically diagnosed advanced non-small lung cancer
- has surgery indication
- age 18 years old or greater
- life expectancy greater than 12 weeks
- ECOG: 0-2
- no prior chemotherapy, radiotherapy in 2 weeks
- Neutrophils≥1.5×10^9/L,platelet≥80×10^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range
- subject provides signed informed consent
Who cannot join
- hypersensitive to study drug
- with a coagulational test unnormal or a bleeding disorder
- infections
- with serious condition which can't stand a surgery
- pregnant or lactating
- principle investigator consider not suitable
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Surgery Research, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 40042
Qunyou Tang, M.D., Ph.D, 13983770929, 13983770929@163.com
qunyou tan, M.D., Ph.D
About this study
Official title: Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.
The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Surgery combined with rAd-p53 gene therapy, Surgery
- Keywords
- p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery combined with rAd-p53 gene therapyDrug
Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy
SurgeryProcedure or surgery
Surgery plus post-surgery chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Surgery plus post-surgery chemotherapy | Active comparator | Surgery plus post-surgery chemotherapy Receives: Procedure: Surgery |
| Surgery combined with rAd-p53 gene therapy | Experimental | Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy Receives: Drug: Surgery combined with rAd-p53 gene therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
determine the 3-years overall survival
Measured: 3 year after the treatment
adverse effects
Measured: from starting treatment to 30 days after treatment
Secondary outcomes (2)
local recurrent rate
Measured: 3 years
quality of life
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qunyou Tan, M.D., Ph.D, Principal investigator, Institute of Surgery Research, Daping Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574729
- Sponsor's protocol ID
- rAd-p53NSCLC
- Acronym
- rAd-p53
- Status last verified
- Jun 2012
- First submitted
- 6 Apr 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
- ClinicalTrials.gov ID
- NCT01574729
- Acronym / sponsor ID
- rAd-p53 / rAd-p53NSCLC
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 10 Apr 2012 (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.
The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.
The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery plus post-surgery chemotherapy | Active comparator | Procedure: SurgerySurgery plus post-surgery chemotherapy |
| Surgery combined with rAd-p53 gene therapy | Experimental | Drug: Surgery combined with rAd-p53 gene therapySurgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- historically diagnosed advanced non-small lung cancer
- has surgery indication
- age 18 years old or greater
- life expectancy greater than 12 weeks
- ECOG: 0-2
Key exclusion criteria (6 listed)
- hypersensitive to study drug
- with a coagulational test unnormal or a bleeding disorder
- infections
- with serious condition which can't stand a surgery
- 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 |
|---|---|---|
| Surgery combined with rAd-p53 gene therapySurgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy | Drug | Surgery combined with rAd-p53 gene therapy |
| SurgerySurgery plus post-surgery chemotherapy | Procedure or surgery | Surgery plus post-surgery chemotherapy |
Primary outcome
overall survival
Time frame: 3 year after the treatment
determine the 3-years overall survival
adverse effects
Time frame: from starting treatment to 30 days after treatment
2 secondary outcomes
local recurrent rate
Time frame: 3 years
quality of life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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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.
Qunyou Tan, M.D., Ph.D principal investigator
Institute of Surgery Research, Daping Hospital, Third Military Medical University
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 Surgery combined with rAd-p53 gene therapy and Surgery in people with Non-small Cell Lung Cancer, 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 8 inclusion and 6 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 Jun 2012. 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 Qunyou Tan, M.D., Ph.D (13983770929, 13983770929@163.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: 3 year after the treatment). 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 Jun 2012.