P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

Phase 2

• Conditions: Advanced Head and Neck Cancer
• Interventions: Drug: rAd-p53; Radiation: radiation; Drug: Cisplatin

• Registration Number: NCT02429037
• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Brief 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.

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 Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-23
• Last Update Submitted: 2015-04-23
• Study First Posted: 2015-04-29
• Last Update Posted: 2015-04-29
• Study Start: 2015-05
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. histopathologically diagnosed head and neck cancer;
2. unresectable, locally advanced;
3. 18 years or older;
4. with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
5. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.

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Exclusion Criteria

1. Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
2. have serious heart, lung function abnormalities or severe diabetes patients;
3. active infection;
4. severe atherosclerosis;
5. AIDS patients;
6. serious thrombotic or embolic events within 6 months;
7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
8. pregnant or lactating women;
9. mental disorder or disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rAd-p53 plus radiation and chemotherapy	rAd-p53	rAd-p53 tumor injection combined with radio- and chemo-therapy.
radiation and chemotherapy	radiation	radiation combined with chemotherapy
rAd-p53 plus radiation and chemotherapy	radiation	rAd-p53 tumor injection combined with radio- and chemo-therapy.
radiation and chemotherapy	Cisplatin	radiation combined with chemotherapy
rAd-p53 plus radiation and chemotherapy	Cisplatin	rAd-p53 tumor injection combined with radio- and chemo-therapy.

Primary Outcome Measures

Name	Time	Method
progression-free survival	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	from starting study treatment until 30 days after the last study treatment	Adverse events
overall survival	three years after starting study treatment	Patients will be followed up until death, withdrawal from study, or until data cut-off after 3 years.

Trial Locations

Locations (1)

Jiangsu cancer hospital; 🇨🇳 Nanjing, Jiangsu, China