Clinical trial · Observational
Electrocautery Resection Combined With HITHOC for Thymic Epithelial Tumors With Pleural Metastasis
Prospective Cohort Study of Electrocautery Resection Combined With Hyperthermic Intrathoracic Chemotherapy for Thymic Epithelial Tumors With Pleural Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pleural Metastasis | — | UNRESOLVED | — |
| Pleural Recurrence | — | UNRESOLVED | — |
| Thymic Carcinoma | Thymus Carcinoma | CURATED_BROADER | 0.80 |
| Thymic Epithelial Tumor | Thymus Epithelial Neoplasm | ALIAS | 0.90 |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic Intrathoracic Chemotherapy (HITHOC) | Procedure | — | UNRESOLVED |
| 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 | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- 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)
Primary outcomes (1)
- measure
- Event-Free Survival (EFS)
- timeFrame
- From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available