Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

Malignant Pleural Effusion Clinical Trial

Official title: Recombinant Adenoviral Human p53 Gene With or Without Cisplatin in Treatment of Malignant Pleural - a Phase 2, Double Blinded, Randomized, Active Controlled Study

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

• NCT number: NCT02429726
• Study type: Interventional
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: Shuanyin Yang, MD
• Phone: 86-18149098803
• Email: yangshuanying66@163.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2015
• Completion date: June 2017