Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. This is a phase 2, double blinded, randomized, 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 original cancer with malignant pleural effusion;

2. 18 years or older;

3. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.

4. 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.