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
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
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)
Adults aged 16-80 years with pathologically confirmed thymic epithelial tumors (thymoma or thymic carcinoma) with pleural dissemination or recurrence, suitable for electrocautery resection and hyperthermic intrathoracic chemotherapy as determined by multidisciplinary team.
Cohort
Prospective
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/SurgeryExtended 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.
Hyperthermic Intrathoracic Chemotherapy (HITHOC)
Procedure/SurgeryTwo 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.
Event-Free Survival (EFS)
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.
Incidence of Grade ≥3 Treatment-Related Adverse Events
Rate of grade ≥3 adverse events according to Clavien-Dindo classification related to surgery or chemotherapy. This includes surgical complications and chemotherapy-related toxicities.
Overall Survival (OS)
Time from disease grouping to death from any cause.
Quality of Life Assessed by EQ-5D
Quality of life assessed using the EuroQol 5 Dimensions (EQ-5D) questionnaire. The EQ-5D visual analog scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better quality of life.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
