Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT05446935
Eligibility Criteria:
Inclusion Criteria:
1. Puncture biopsy, thoracoscopic/mediastinal biopsy, or surgery to confirm pathologically thymic epithelial tumor (TETs)
2. Imaging examination shows TETs with pleural spread or recurrence, and the mediastinal MDT team considers HITOC suitable.
3. Patients with ≥16 and ≤80 years old.
4. ASA I-II.
5. The patients should have no functional disorders in the main organs.
6. There was no history of other malignant carcinomas.
7. The duration from the last chemotherapy was \>4 weeks, the duration from the last radiotherapy was \>6 weeks, and the duration from the last immunotherapy was \>6 weeks.
8. Not allergic to cisplatin or doxorubicin.
9. The patients should be able to understand our research and sign the informed consent.
Exclusion Criteria:
1. Imaging or pathological examination shows TETs without pleural spread or recurrence, or with pericardial dissemination or extrathoracic metastasis.
2. Patients with lymphoid system, neurogenic or reproductive system carcinoma.
3. Patients who have been receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
4. Patients with myasthenia gravis in unstable or acute exacerbation stage.
5. The patients have been proven history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control.
6. The patients have the severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under-treatment of thrombolysis or anticoagulant therapy.
7. Female who is positive for a serum pregnancy test or during lactation period.
8. The patients have a history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation.
9. The patients have a history of peripheral nerve system disorders, obvious mental disorders, or central nerve system disorders.
10. The patients attend other clinical trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT05446935
Study Brief:
Protocol Section:
NCT05446935