Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jul 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach called hyperthermic intrathoracic chemotherapy (HITOC) for patients with thymic epithelial tumors (TETs) that have spread to the pleura, the lining around the lungs. After surgical removal of as much of the tumor as possible, HITOC aims to help control any remaining cancer cells. The trial is looking for participants who are between 16 and 80 years old, have had a confirmed diagnosis of TETs, and have imaging tests showing that their cancer has spread or come back. It’s important that patients do not have any other significant health issues and have been free of certain treatments for enough time before joining the study.

If you decide to participate, you’ll undergo surgery followed by HITOC, which involves administering two types of chemotherapy drugs in a heated solution directly into the chest. This treatment is being tested to see how well it works and how safe it is for patients like you. As the trial is currently recruiting, it’s a great opportunity for those eligible to potentially benefit from this innovative treatment while contributing to important research.

Gender

ALL

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.