Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion

NCT07670338 | Not Yet Recruiting DMC

• 1 other identifier: ZDYN-2024-A-147
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Malignant Pleural Effusions (Mpe)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate of pleural effusion (ORR)

  Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment

Secondary Outcomes (6)

• Duration of Response (DoR)

  At 2, 4, 8, and 12 weeks after treatment

• Progression-Free Survival (PFS)

  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)

  From date of treatment until the date of death from any cause, assessed up to 100 months

• Degree of dyspnea

  At 2, 4, 8, and 12 weeks after treatment

• ECOG score

  At 2, 4, 8, and 12 weeks after treatment

Study Arms (2)

experimental group

EXPERIMENTAL

Other: Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage

control group

PLACEBO COMPARATOR

Drug: Placebo granules plus chest tube drainage and intrapleural bevacizumab injection

Interventions

Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage OTHER

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.

experimental group

Placebo granules plus chest tube drainage and intrapleural bevacizumab injection DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Traditional Chinese Medicine (TCM) syndrome differentiation classified as Xuanyin (suspension fluid) with fluid retention in the chest and hypochondrium;
• Expected survival of at least 3 months;
• Voluntarily signed informed consent before treatment;
• No contraindications to chest tube placement for drainage;
• Adequate major organ function, including:
• Complete blood count:
• White blood cell count ≥ 4.0×10⁹/L Absolute neutrophil count ≥ 1.5×10⁹/L Platelet count ≥ 100×10⁹/L Hemoglobin ≥ 90 g/L
• Blood biochemistry:
• Total bilirubin ≤ 1.5×ULN ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
• Coagulation function:
• International normalized ratio (INR) ≤ 1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5×ULN

You may not qualify if:

• 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;
• Prior history of empyema or chylothorax;
• Participation in another clinical trial within 4 weeks before signing informed consent;
• Known allergy to any component of the study drugs;
• Severe bleeding tendency or active bleeding;
• Uncontrolled severe hypertension;
• Recent (within 3 months) thromboembolic events, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, etc.;
• Prior severe adverse reactions to intravenous bevacizumab, such as severe proteinuria, gastrointestinal perforation, hypertensive crisis, etc.;
• Severe cardiac, hepatic, or renal insufficiency;
• Pregnant or breastfeeding women;
• Subjects with other active infectious diseases in the acute phase;
• Any other factors that, in the investigator's judgment, may lead to premature termination of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse, family or social factors that may affect the subject's safety or compliance.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (7)

Wuhan First Hospital

Wuhan, Hebei, 430022, China

Location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

Weifang Traditional Chinese Medicine Hospital 或 Weifang Traditional Chinese Hospital

Weifang, Shandong, 261041, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200437, China

Location

Shanghai Tenth People's Hospital Chongming Branch

Shanghai, Shanghai Municipality, 202157, China

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Myeloproliferative Disorder, Chronic, with Eosinophilia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Central Study Contacts

Ming Zhang

CONTACT

18017320233; gason2000@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CN (7)