Prospective Cohort Study of Electrocautery Resection Combined With Hyperthermic Intrathoracic Chemotherapy for Thymic Epithelial Tumors With Pleural Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Electrocautery Resection + HITHOC
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 intrathoracic chemotherapy (HITHOC) with cisplatin and doxorubicin.
干预措施: 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 (Procedure)
Electrocautery Resection + HITHOC
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 intrathoracic chemotherapy (HITHOC) with cisplatin and doxorubicin.
干预措施: Hyperthermic Intrathoracic Chemotherapy (HITHOC) (Procedure)
结局指标
主要结局
Event-Free Survival (EFS)
时间窗: From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months
Time from treatment start to first occurrence of local recurrence, distant metastasis, or death from any cause. Events are assessed through regular imaging and clinical follow-up.
次要结局
- Incidence of Grade ≥3 Treatment-Related Adverse Events(From treatment initiation through 30 days post-treatment)
- Overall Survival (OS)(From enrollment to death from any cause, assessed up to 36 months)
- Quality of Life Assessed by EQ-5D(Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months)
研究者
Jiang Fan
Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine