Меню
Набор скоро начнётся NCT07328074

Electrocautery Resection Combined With HITHOC for Thymic Epithelial Tumors With Pleural Metastasis

— Наблюдательное Thymic Epithelial Tumor Thymoma Thymic Carcinoma Pleural Metastasis

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: Patients with thymic epithelial tumors with pleural metastasis or recurrence who undergo extended thymectomy with electrocautery resection of pleural metastases followed by two cycles of hyperthermic, Hyperthermic Intrathoracic Chemotherapy (HITHOC).
Кому может быть актуально
Состояния в реестре: Thymic Epithelial Tumor, Thymoma, Thymic Carcinoma, Pleural Metastasis. Базовые параметры: 16 лет — 80 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective Cohort Study of Electrocautery Resection Combined With Hyperthermic Intrathoracic Chemotherapy for Thymic Epithelial Tumors With Pleural Metastasis

Обзор

The goal of this observational study is to explore the effectiveness of electrocautery resection combined with hyperthermic intrathoracic chemotherapy (HITHOC) in patients with thymic epithelial tumors with pleural metastasis or recurrence. The study aims to: * Evaluate whether this combined treatment improves event-free survival in patients with pleural metastasis from thymic epithelial tumors * Assess the rates of grade ≥3 treatment-related adverse events * Examine how this treatment affects patients' quality of life Participants will: * Undergo extended thymectomy with electrocautery resection of pleural metastases * Receive two cycles of hyperthermic intrathoracic chemotherapy with cisplatin and doxorubicin at 42-43°C, 2-4 days apart * Complete quality of life questionnaires (EQ-5D) at baseline and regular intervals * Have regular follow-up visits with imaging and clinical assessments for up to 36 months to monitor for disease recurrence or progression

Вмешательства

  • Процедура Patients with thymic epithelial tumors with pleural metastasis or recurrence who undergo extended thymectomy with electrocautery resection of pleural metastases followed by two cycles of hyperthermic
    Extended thymectomy with electrocautery ablation and resection of pleural metastases. Larger lesions (\>1cm) are thoroughly ablated with electrocautery followed by complete resection. Smaller lesions (≤1cm) that are difficult to resect are thoroughly ablated with electrocautery.
  • Процедура Hyperthermic Intrathoracic Chemotherapy (HITHOC)
    Two cycles of hyperthermic intrathoracic chemotherapy performed 2-4 days apart using BR-TRG-I device. Chemotherapy solution containing cisplatin (50 mg/m²) and doxorubicin (25 mg/m²) is circulated at 400 mL/min with inflow temperature maintained at 42-43°C for 60 minutes per cycle.

Первичные конечные точки

  • Event-Free Survival (EFS) [Срок оценки: From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months]
Вторичные конечные точки (3)
  • Incidence of Grade ≥3 Treatment-Related Adverse Events [Срок оценки: From treatment initiation through 30 days post-treatment]
  • Overall Survival (OS) [Срок оценки: From enrollment to death from any cause, assessed up to 36 months]
  • Quality of Life Assessed by EQ-5D [Срок оценки: Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months]

Критерии участия

Критерии включения

  • Pathologically confirmed thymic epithelial tumor (TET)
  • Imaging evidence of thymic epithelial tumor with pleural dissemination or recurrence, deemed suitable for HITHOC by multidisciplinary thoracic team
  • Age ≥16 years and ≤80 years
  • American Society of Anesthesiologists (ASA) physical status classification I-II
  • Normal major organ function
  • No history of other malignancies
  • Prior chemotherapy completed >4 weeks, radiotherapy >6 weeks, immunotherapy >6 weeks before enrollment
  • No allergy to cisplatin or doxorubicin
  • Able to understand the study content and provide informed consent

Критерии исключения

  • Evidence of extrathoracic metastasis on imaging or pathological examination
  • Myasthenia gravis in unstable phase or acute exacerbation
  • Severe systemic comorbidities, such as active infection, poorly controlled diabetes, coagulopathy, bleeding tendency, or ongoing thrombolytic/anticoagulation therapy
  • Positive serum pregnancy test or lactation (females)
  • History of organ transplantation (including autologous bone marrow transplantation and peripheral blood stem cell transplantation)
  • History of peripheral nervous system disease, significant psychiatric disorder, or central nervous system disease
  • Currently participating in other clinical trials

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Shanghai General Hospital, Department of Thoracic Surgery — Шанхай

Идентификаторы

NCT: NCT07328074 · 20250519101831997

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗