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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-80
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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)

Treatment groups

70 Participants
are divided into 1 treatment group