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Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion
Sponsor: Shanghai Chest Hospital
Summary
The goal of this clinical trial is to determine whether the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage is effective in treating malignant pleural effusion. It will also evaluate the safety of this combination therapy. The main questions it aims to answer include: Does the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage improve the objective response rate (ORR) of pleural effusion in patients with malignant pleural effusion? Does this combination therapy affect the duration of response (DoR), progression-free survival (PFS), overall survival (OS), degree of dyspnea, quality of life, and Traditional Chinese Medicine (TCM) pattern/syndrome evaluation in patients with malignant pleural effusion? Participants will: Receive intrapleural injection of bevacizumab via chest tube drainage, and take either Xuanyin Ning Formula or placebo granules daily for 8 weeks. Undergo ultrasound assessment of pleural effusion at 2, 4, 8, and 12 weeks after the first intrapleural injection during closed chest drainage, followed by ultrasound assessments every 3 months (±7 days) until pleural effusion progression.
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of Xuan Yin Ning Formula Combined With Intrapleural Injection of Bevacizumab for the Treatment of Malignant Pleural Effusion.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2026-06-01
Completion Date
2028-09-01
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage
After chest tube drainage, bevacizumab 300 mg per dose, dissolved in 50 ml of normal saline, is injected intrapleurally. The injection may be repeated after 2 weeks depending on the control of pleural effusion. Xuanyin Ning is taken as 2 sachets per day, one sachet dissolved in water and taken orally in the morning and one in the evening. Each treatment cycle is 4 weeks, and at least 2 cycles are required.
Placebo granules plus chest tube drainage and intrapleural bevacizumab injection
After chest tube drainage, bevacizumab 300 mg per dose, dissolved in 50 ml of normal saline, is injected intrapleurally. The injection may be repeated after 2 weeks depending on the control of pleural effusion. Placebo granules are taken as 2 sachets per day, one sachet dissolved in water and taken orally in the morning and one in the evening. Each treatment cycle is 4 weeks, and at least 2 cycles are required.
Locations (7)
Wuhan First Hospital
Wuhan, Hebei, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Weifang Traditional Chinese Medicine Hospital 或 Weifang Traditional Chinese Hospital
Weifang, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital Chongming Branch
Shanghai, Shanghai Municipality, China