Clinical trial · Interventional
Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion
Recombinant Adenoviral Human p53 Gene With or Without Cisplatin in Treatment of Malignant Pleural - a Phase 2, Double Blinded, Randomized, Active Controlled Study
NCT02429726CI-TRIAL-00017702unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| rAdp53 | Drug | — | UNRESOLVED |
| rAdp53 plus cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- rAdp53
- description
- 2 x 10\^12 viral particles of rAdp53 gene are given in 40 ml of saline by intra-cavity infusion at day of 7, 15 and 21
- interventionNames
- Drug: rAdp53
- type
- ACTIVE_COMPARATOR
- label
- cisplatin
- description
- cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21
- interventionNames
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- rAdp53 plus cisplatin
- description
- 2 x 10\^12 viral particles of rAdp53 gene and cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.