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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
308
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.
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.
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
Objective Response Rate of pleural effusion (ORR)
Time frame: Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment
Duration of Response (DoR)
Time frame: At 2, 4, 8, and 12 weeks after treatment
Progression-Free Survival (PFS)
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (OS)
Time frame: From date of treatment until the date of death from any cause, assessed up to 100 months
Degree of dyspnea
Time frame: At 2, 4, 8, and 12 weeks after treatment
ECOG score
The ECOG score is a widely used clinical tool for quantifying a cancer patient's general well-being and functional capacity in daily life. It is primarily employed in oncology trials, treatment planning, and prognosis assessment. The scale ranges from 0 to 5, with higher numbers indicating greater disability
Time frame: At 2, 4, 8, and 12 weeks after treatment
Traditional Chinese Medicine (TCM) syndrome evaluation
Quantification: The scale standardizes the evaluation of clinical symptoms, signs, and tongue/pulse findings, which are traditionally assessed through the four examinations (inspection, hearing/smelling, inquiry, and palpation). Objectivity: It aims to improve the objectivity and standardization of TCM diagnosis and treatment evaluation. Efficacy Evaluation: It is frequently used to calculate a "total effective rate" based on the reduction in syndrome scores after treatment. Scoring: Symptoms are typically graded on a scale (e.g., 0 for normal, 2 for mild, 4 for moderate, 6 for severe), and the total score reflects the overall severity of the syndrome
Time frame: At 2, 4, 8, and 12 weeks after treatment
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