Malignant Pleural Effusion
Conditions
Keywords
malignant pleural effusion, p53 gene therapy, cisplatin
Brief 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.
Detailed description
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. Study design: phase 2, double blinded, randomized, active controlled.Ninety patients with malignant pleural effusion, who meet the study inclusion criteria and none of exclusion criteria, will be randomized into 3 treatment groups: rAd-p53, cisplatin, and rAd-p53 combined with cisplatin. The study endpoints are objective response rate, Karnofsky score, effusion-free survival, and safety.
Interventions
DRUGrAdp53
Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion
DRUGCisplatin
Cisplatin will be administered by intra chest cavity infusion
DRUGrAdp53 plus cisplatin
Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion
Sponsors
Shenzhen SiBiono GeneTech Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | from starting study treatment to 3 months | the rate of complete response and partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effusion-free survival | from starting study treatment to 2 years | effusion-free survival |
| Karnofsky Performance Status | from starting study treatment to 2 years | — |
| adverse events | from starting study treatment to 30 days after the last treatment | — |
Countries
China
Contacts
Primary ContactShuanyin Yang, MD
Backup ContactWei Wang, MD
Outcome results
None listed