Not Yet RecruitingNot Applicable

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

China70 participantsStarted 2026-02

Plain-language 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

Who can participate

Age range

16 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-Free Survival (EFS)

Timeframe: From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months

Trial details

NCT IDNCT07328074

SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-02

View on ClinicalTrials.gov More Thymic Epithelial Tumor trials