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

SiBiono

Status and phase: Unknown; Phase 2

Conditions: Advanced Head and Neck Cancer

Treatments: Drug: Cisplatin; Drug: rAd-p53; Radiation: radiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02429037

rAd-p53-J1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

rAd-p53 plus radiation and chemotherapy

Experimental group

Description:

rAd-p53 tumor injection combined with radio- and chemo-therapy.

Treatment:

Drug: Cisplatin

Drug: rAd-p53

Radiation: radiation

radiation and chemotherapy

Active Comparator group

Description:

radiation combined with chemotherapy

Treatment:

Drug: Cisplatin

Radiation: radiation