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Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion (XYN-Bev MPE)

29 de junho de 2026 atualizado por: Zhang Ming, Shanghai Chest Hospital

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.

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

308

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Hebei
      • Wuhan, Hebei, China, 430022
        • Wuhan First Hospital
        • Contato:
    • Henan
      • Xinxiang, Henan, China, 453100
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contato:
    • Shandong
      • Weifang, Shandong, China, 261041
        • Weifang Traditional Chinese Medicine Hospital 或 Weifang Traditional Chinese Hospital
        • Contato:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Shanghai Chest Hospital
        • Contato:
      • Shanghai, Shanghai Municipality, China, 200437
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
        • Contato:
      • Shanghai, Shanghai Municipality, China, 200032
        • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
        • Contato:
          • Zhongqi Wang
          • Número de telefone: 18917763093
          • E-mail: aledx@sina.com
      • Shanghai, Shanghai Municipality, China, 202157
        • Shanghai Tenth People's Hospital Chongming Branch
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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:

    1. 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

    2. 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)

    3. Coagulation function:

      International normalized ratio (INR) ≤ 1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5×ULN

    4. Blood glucose: within normal range, or diabetic patients under treatment with stable blood glucose control;
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study drug administration, and must use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study period and for at least 3 months after the last dose. -Male subjects with a partner of childbearing potential must use effective contraception during the study period and for 3 months after the last dose;
  • Good subject compliance, able to follow up for efficacy and adverse events/reactions as required by the protocol.

Exclusion Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Grupo experimental
Outro: 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.
Comparador de Placebo: grupo de controle
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Objective Response Rate of pleural effusion (ORR)
Prazo: Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment
Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Duration of Response (DoR)
Prazo: At 2, 4, 8, and 12 weeks after treatment
At 2, 4, 8, and 12 weeks after treatment
Progression-Free Survival (PFS)
Prazo: 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
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)
Prazo: From date of treatment until the date of death from any cause, assessed up to 100 months
From date of treatment until the date of death from any cause, assessed up to 100 months
Degree of dyspnea
Prazo: At 2, 4, 8, and 12 weeks after treatment
At 2, 4, 8, and 12 weeks after treatment
ECOG score
Prazo: At 2, 4, 8, and 12 weeks after treatment
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
At 2, 4, 8, and 12 weeks after treatment
Traditional Chinese Medicine (TCM) syndrome evaluation
Prazo: At 2, 4, 8, and 12 weeks after treatment

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai Chest Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de setembro de 2028

Conclusão do estudo (Estimado)

1 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de junho de 2026

Primeira postagem (Real)

26 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ZDYN-2024-A-147

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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