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

29. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

308

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Hebei
      • Wuhan, Hebei, Kina, 430022
        • Wuhan First Hospital
        • Ta kontakt med:
    • Henan
      • Xinxiang, Henan, Kina, 453100
        • The First Affiliated Hospital of Xinxiang Medical University
        • Ta kontakt med:
    • Shandong
      • Weifang, Shandong, Kina, 261041
        • Weifang Traditional Chinese Medicine Hospital 或 Weifang Traditional Chinese Hospital
        • Ta kontakt med:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200030
        • Shanghai Chest Hospital
        • Ta kontakt med:
      • Shanghai, Shanghai Municipality, Kina, 200437
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
        • Ta kontakt med:
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
        • Ta kontakt med:
      • Shanghai, Shanghai Municipality, Kina, 202157
        • Shanghai Tenth People's Hospital Chongming Branch
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: forsøksgruppe
Annen: 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.
Placebo komparator: kontrollgruppe
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Objective Response Rate of pleural effusion (ORR)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of Response (DoR)
Tidsramme: At 2, 4, 8, and 12 weeks after treatment
At 2, 4, 8, and 12 weeks after treatment
Progression-Free Survival (PFS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: At 2, 4, 8, and 12 weeks after treatment
At 2, 4, 8, and 12 weeks after treatment
ECOG score
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai Chest Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

24. juni 2026

Først lagt ut (Faktiske)

26. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ZDYN-2024-A-147

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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