NCT02429726

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Pleural Effusion

Interventions

Type	Name	Description
DRUG	rAdp53	Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion
DRUG	Cisplatin	Cisplatin will be administered by intra chest cavity infusion
DRUG	rAdp53 plus cisplatin	Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-04-29
• Last updated: 2015-04-29

Locations

1 site across 1 country: China