Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion
ConditionMalignant Pleural Effusions (Mpe)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Chest Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Patients with advanced non-squamous non-small cell lung cancer who have failed at least first-line systemic therapy;
Presence of unilateral pleural effusion confirmed as malignant by pathology or cytology, with at least moderate volume requiring drainage (moderate pleural effusion defined as: supine ultrasound examination showing pleural effusion ≥3 cm, or sitting ultrasound examination showing pleural effusion ≥4 cm,accompanied by clinical symptoms such as chest tightness and dyspnea);
Age 18-75 years;
ECOG performance status 0-2;
Disqualifiers
The location of pleural effusion is unsuitable for drainage, or the patient would not benefit from intrapleural drug administration (e.g., severe loculation/septation);
Other contraindications to indwelling chest tube placement;
Pleural effusion with active infection;
Prior history of ipsilateral chest tube drainage and intrapleural anti-tumor drug therapy or pleurodesis;
Trial design
Treatments tested in this trial
- Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage
- Placebo granules plus chest tube drainage and intrapleural bevacizumab injection
Treatment groups
308 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov