Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion (XYN-Bev MPE)
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ming Zhang
- 電話番号：18017320233
- メール：gason2000@126.com
研究場所
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Hebei
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Wuhan、Hebei、中国、430022
- Wuhan First Hospital
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コンタクト：
- Zuowei Hu
- 電話番号：13871029959
- メール：827823053@qq.com
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Henan
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Xinxiang、Henan、中国、453100
- The First Affiliated Hospital of Xinxiang Medical University
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コンタクト：
- Xiaohong Kang
- 電話番号：19838276658
- メール：394161891@qq.com
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Shandong
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Weifang、Shandong、中国、261041
- Weifang Traditional Chinese Medicine Hospital 或 Weifang Traditional Chinese Hospital
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コンタクト：
- Chaoguang Yan
- 電話番号：19953614610
- メール：19953614610@126.com
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200030
- Shanghai Chest Hospital
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コンタクト：
- Ming Zhang
- 電話番号：18017320233
- メール：gason2000@126.com
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Shanghai、Shanghai Municipality、中国、200437
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
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コンタクト：
- Yabin Gong
- 電話番号：18918923873
- メール：gongyabin@hotmail.com
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Shanghai、Shanghai Municipality、中国、200032
- Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
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コンタクト：
- Zhongqi Wang
- 電話番号：18917763093
- メール：aledx@sina.com
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Shanghai、Shanghai Municipality、中国、202157
- Shanghai Tenth People's Hospital Chongming Branch
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コンタクト：
- Yeyun Lu
- 電話番号：18916582319
- メール：307997868@qq.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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:
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
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：実験グループ
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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.
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プラセボコンパレーター：対照群
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Objective Response Rate of pleural effusion (ORR)
時間枠：Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment
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Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Duration of Response (DoR)
時間枠：At 2, 4, 8, and 12 weeks after treatment
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At 2, 4, 8, and 12 weeks after treatment
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Progression-Free Survival (PFS)
時間枠：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
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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
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Overall Survival (OS)
時間枠：From date of treatment until the date of death from any cause, assessed up to 100 months
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From date of treatment until the date of death from any cause, assessed up to 100 months
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Degree of dyspnea
時間枠：At 2, 4, 8, and 12 weeks after treatment
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At 2, 4, 8, and 12 weeks after treatment
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ECOG score
時間枠：At 2, 4, 8, and 12 weeks after treatment
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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
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At 2, 4, 8, and 12 weeks after treatment
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Traditional Chinese Medicine (TCM) syndrome evaluation
時間枠：At 2, 4, 8, and 12 weeks after treatment
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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
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。