About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- 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)