Advanced Head and Neck CancerPhase 2NCT02429037
P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer
A Phase 2 study testing rAd-p53, radiation and Cisplatin in people with Advanced Head and Neck Cancer, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
Trial summary
The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Head and Neck Cancer
- What is being tested?
- rAd-p53, radiation and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2018
- 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
- histopathologically diagnosed head and neck cancer;
- unresectable, locally advanced;
- 18 years or older;
- with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
Who cannot join
- Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
- have serious heart, lung function abnormalities or severe diabetes patients;
- active infection;
- severe atherosclerosis;
- AIDS patients;
- serious thrombotic or embolic events within 6 months;
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- renal insufficiency requiring hemodialysis or peritoneal dialysis;
- pregnant or lactating women;
- mental disorder or disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu cancer hospital
Nanjing, Jiangsu, 210000
Xia He, MD, PhD, 86-13601458518, 13601458515@qq.com
Jianfeng Wu, MD, PhD, 86-13923753040, 595864485@qq.com
About this study
Official title: Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study
The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.
Read the detailed description
To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.
- Conditions
- Advanced Head and Neck Cancer
- Keywords
- p53, gene therapy, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rAd-p53Drug
Also called p53 gene therapy
multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle.
radiationRadiation
radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.
CisplatinDrug
Also called chemotherapy: cisplatin
Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15
| Study group | Role | What they receive |
|---|---|---|
| rAd-p53 plus radiation and chemotherapy | Experimental | rAd-p53 tumor injection combined with radio- and chemo-therapy. Receives: Drug: rAd-p53; Radiation: radiation; Drug: Cisplatin |
| radiation and chemotherapy | Active comparator | radiation combined with chemotherapy Receives: Radiation: radiation; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.
Measured: three years after starting treatment
Secondary outcomes (2)
Adverse events
Adverse events
Measured: from starting study treatment until 30 days after the last study treatment
overall survival
Patients will be followed up until death, withdrawal from study, or until data cut-off after 3 years.
Measured: three years after starting study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Head and Neck 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
- 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
- NCT02429037
- Sponsor's protocol ID
- rAd-p53-J1002
- Status last verified
- Mar 2015
- First submitted
- 20 Apr 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study
- ClinicalTrials.gov ID
- NCT02429037
- Acronym / sponsor ID
- rAd-p53-J1002
- Conditions
- Advanced Head and Neck Cancer
- Keywords
- p53, gene therapy, head and neck cancer
- 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
- May 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Apr 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.
The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.
Detailed description
To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rAd-p53 plus radiation and chemotherapy | Experimental | Drug: rAd-p53, Radiation: radiation, Drug: CisplatinrAd-p53 tumor injection combined with radio- and chemo-therapy. |
| radiation and chemotherapy | Active comparator | Radiation: radiation, Drug: Cisplatinradiation combined with chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histopathologically diagnosed head and neck cancer;
- unresectable, locally advanced;
- 18 years or older;
- with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
Key exclusion criteria (9 listed)
- Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
- have serious heart, lung function abnormalities or severe diabetes patients;
- active infection;
- severe atherosclerosis;
- AIDS patients;
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 |
|---|---|---|
| rAd-p53Also: p53 gene therapymulti-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle. | Drug | rAd-p53 plus radiation and chemotherapy |
| radiationradiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks. | Radiation | rAd-p53 plus radiation and chemotherapy, radiation and chemotherapy |
| CisplatinAlso: chemotherapy: cisplatinCisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15 | Drug | rAd-p53 plus radiation and chemotherapy, radiation and chemotherapy |
Primary outcome
progression-free survival
Time frame: three years after starting treatment
Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.
2 secondary outcomes
Adverse events
Time frame: from starting study treatment until 30 days after the last study treatment
overall survival
Time frame: three years after starting study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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.
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 rAd-p53, radiation and Cisplatin in people with Advanced Head and Neck 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 5 inclusion and 9 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 29 Apr 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 Xia He, MD, PhD (86-13601458518, 13601458515@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: three years after starting treatment). 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 29 Apr 2015.