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

NCT ID: NCT07328074

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2031-02-28

Brief 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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Electrocautery Resection + HITHOC

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.

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

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jiang Fan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai General Hospital, Department of Thoracic Surgery

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

20250519101831997

Identifier Type: -

Identifier Source: org_study_id