Clinical Trial: Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothora

Brief Summary: The purpose of this multi-center clinical trial is to verify more effective on local control of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar) compared with cisplatin perfusion, with acceptable side effects.

Detailed Summary: Malignant pleural effusion, which can malfunction of circulatory and respiratory systems, is a common complication in advanced NSCLC, finally decreases the quality of life and lifespan. Nowadays, it is still a challenge to effectively control malignant pleural effusion. In this multi-center randomized and controlled clinical trial, 134 NSCLC patients diagnosed as malignant pleural effusion in the first time will enroll. Based on systemic chemotherapy and pleural cavity perfusion, all eligible patients are randomly assigned into treatment group (recombinant human adenovirus type 5 and Endostatin injections) and control group (cisplatin) with ratio 1:1. Local control rate and side effects are record respectively. The anticipation is that treatment group obtains faster and longer control of pleural effusion.
Sponsor: Xinqiao Hospital of Chongqing

Current Primary Outcome: Objective response rate (ORR) of malignant pleural effusions [ Time Frame: up to 3 years ]

Assessed by WHO Cancerous effusion scoring system


Original Primary Outcome: Objective response rate (ORR) of malignant pleural effusions [ Time Frame: up to 3 years ]

Assessed by RECIST 1.1


Current Secondary Outcome: progression-free survival [ Time Frame: up to 3 years ]

Original Secondary Outcome: Same as current

Information By: Xinqiao Hospital of Chongqing

Dates:
Date Received: October 12, 2015
Date Started: October 2016
Date Completion: December 2018
Last Updated: October 20, 2016
Last Verified: October 2016