Electrocautery Resection Combined With HITHOC for Thymic Epithelial Tumors With Pleural Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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).
- Who it may be relevant to
- Registry conditions: Thymic Epithelial Tumor, Thymoma, Thymic Carcinoma, Pleural Metastasis. Basic parameters: 16 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort Study of Electrocautery Resection Combined With Hyperthermic Intrathoracic Chemotherapy for Thymic Epithelial Tumors With Pleural Metastasis
Overview
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
Interventions
- 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
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. - 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.
Primary outcome measures
- Event-Free Survival (EFS) [Time frame: From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months]
Secondary outcome measures (3)
- Incidence of Grade ≥3 Treatment-Related Adverse Events [Time frame: From treatment initiation through 30 days post-treatment]
- Overall Survival (OS) [Time frame: From enrollment to death from any cause, assessed up to 36 months]
- Quality of Life Assessed by EQ-5D [Time frame: Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai General Hospital, Department of Thoracic Surgery — Shanghai
Identifiers
NCT: NCT07328074 · 20250519101831997