Clinical Trial: Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Prospective, Multicenter, Randomized Controlled Clinical Trial of Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer
Brief Summary: The purpose of this study is to explore the efficacy and safety of different doses of bevacizumab injection in the treatment of malignant pleural effusion in patients with advanced non-squamous non-small cell lung cancer.
Detailed Summary:
This study is a prospective, multicenter, randomized, phase II clinical study. 87 patients will be recruited.
Group A (low dose group)
Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group B (medium dose group)
Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group C (high dose group)
Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Main evaluation criteria: pleural effusion objective response rate(ORR) (WHO standard)
Secondary evaluation criteria: pleural fluid time to progression (TTP), overall survival (OS), ORR, QOL scores (Quality of Life Questionnaire-lung cancer) and KPS, and safety (NCI CTCAE V4.03)
Sponsor: Beijing Cancer Hospital
Current Primary Outcome: Pleural effusion ORR [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pleural fluid TTP [ Time Frame: 1 year ]
- OS [ Time Frame: 1 year ]
- ORR [ Time Frame: 1 year ]
- QOL scores [ Time Frame: 2 month ]
- Safety (NCI CTCAE V4.03) [ Time Frame: 2 month ]
Original Secondary Outcome: Same as current
Information By: Beijing Cancer Hospital
Dates:
Date Received: October 18, 2016
Date Started: October 2016
Date Completion: October 2019
Last Updated: October 20, 2016
Last Verified: October 2016