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Набор скоро начнётся NCT07358520

Clinical Study on the Use of Huaier Granules for the Treatment of Proteinuria Related to Bevacizumab and Anlotinib in Lung Cancer Patients

Фаза IV С лечением Proteinuria

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Huaier Granule, Anlotinib and Bevacizumab.
Кому может быть актуально
Состояния в реестре: Proteinuria. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective, Multicenter, Parallel-Controlled Clinical Study on the Use of Huaier Granules for the Treatment of Bevacizumab- and Anlotinib-Related Proteinuria in Lung Cancer Patients

Обзор

This study is a prospective, multicenter, parallel-controlled clinical trial designed to evaluate the therapeutic efficacy of Huaier Granules for proteinuria occurring in lung cancer patients undergoing treatment with either Bevacizumab or Anlotinib.

Подробное описание

This study is a prospective, multicenter, parallel-controlled exploratory trial. It plans to enroll 40 subjects diagnosed with malignant lung tumors, who will visit the selected research centers from October 2025 to October 2026. All subjects will be assigned to either the control group or the experimental group based on clinical management and their own preference. Subjects in the control group will receive no therapeutic intervention, while those in the experimental group will be administered Huaier Granules.Throughout the study period, the planned duration for subject recruitment and enrollment is 12 months. The total follow-up duration for enrolled subjects is 48 weeks. After enrollment, subjects will be followed up every 2 weeks during the first 8 weeks, and then every 4 weeks thereafter. Follow-ups will continue until the study ends, the subject withdraws from the study for any reason, is lost to follow-up, or dies, whichever occurs first.

Вмешательства

  • Препарат Huaier Granule
    Take orally, 10g each time, three times daily.
  • Препарат Anlotinib and Bevacizumab
    Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage.

Первичные конечные точки

  • 16-week Efficacy Rate for Proteinuria Treatment [Срок оценки: Start of treatment until 16-week follow-up]
Вторичные конечные точки (3)
  • 48-week Recurrence Rate for Proteinuria Treatment [Срок оценки: Start of treatment until 48-week follow-up]
  • 48-week Resumption and Discontinuation Rates for Bevacizumab or Anlotinib after Proteinuria Treatment [Срок оценки: Start of treatment until 48-week follow-up]
  • Incidence and Severity of Other Adverse Reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) after 48 weeks of Proteinuria Treatment [Срок оценки: Start of treatment until 48-week follow-up]

Критерии участия

Критерии включения

  • Age ≥18 years;
  • Histopathologically confirmed diagnosis of lung cancer;
  • Receiving Bevacizumab or Anlotinib treatment;
  • Positive urine protein detection, with 0.15g < 24-hour urinary protein quantification < 3.5g;
  • No treatment with Huaier Granules within one month prior to enrollment;
  • Expected survival time not less than 6 months;
  • Voluntary participation in this study and provision of signed informed consent.

Критерии исключения

  • Known allergy, contraindication, or caution to any component of Huaier Granules;
  • Inability to take oral medication;
  • Required or ongoing use of drugs known to potentially affect proteinuria, including but not limited to ACE inhibitors, glucocorticoids (>3 weeks), and Chinese patent medicines (as per respective drug prescribing information);
  • Proteinuria caused by underlying diseases, including but not limited to nephropathy, hypertension, urinary tract infection, systemic lupus erythematosus, multiple myeloma, etc.;
  • Women who are pregnant, breastfeeding, or planning pregnancy;
  • Currently participating in other clinical trials investigating drugs for treating proteinuria;
  • Refusal to cooperate with follow-up;
  • Any other reasons deemed by the investigator as unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Xuzhou Central Hospital — Xuzhou
  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07358520 · HE-202508

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗