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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
• Treatments: Cisplatin

Criteria

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.