Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion

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.

NCT Number	NCT07670338
Lead Sponsor	Shanghai Chest Hospital
Conditions	Malignant Pleural Effusions (Mpe)
Enrollment	308 participants
Start Date	2026-06-01
Primary Completion	2028-09-01 (estimated)
Study Completion	2028-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-01