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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Thymoma; Thymic Epithelial Tumor; Pleural Recurrence; Thymic Carcinoma; Pleural Metastasis

Treatments: Procedure: 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: Hyperthermic Intrathoracic Chemotherapy (HITHOC)

Study type: Observational

Funder types: Other

Identifiers

NCT07328074

20250519101831997

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

70 participants in 1 patient group

Electrocautery Resection + HITHOC

Description:

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.

Treatment:

Procedure: Hyperthermic Intrathoracic Chemotherapy (HITHOC)

Procedure: 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