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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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

Primary outcome measure(s)

• Event-Free Survival (EFS) — 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.

Trial sites (1)

More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China

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