Treatment for thymic tumors with pleural spread using heated chemotherapy

Cytoreductive Surgery and Hyperthermic Intrathoracic Chemotherapy for the Treatment of Thymic Epithelial Malignancies With Pleural Spread or Recurrence (CHOICE): a Prospective, Open, Single-arm Study Choice

This study tests if using heated chemotherapy can help patients with thymic tumors that have spread to the lining of the lungs feel better after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 16 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy, doxorubicin
• Locations: 1 site (Shanghai)
• Trial ID: NCT05446935 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of hyperthermic intrathoracic chemotherapy (HITOC) as an additional treatment for patients with thymic epithelial tumors (TETs) that have spread to the pleura or recurred after surgery. The approach involves administering chemotherapy agents doxorubicin and cisplatin in a heated environment to enhance their effectiveness. Patients eligible for this trial must have undergone surgical cytoreduction and be within specific age and health criteria. The study aims to evaluate the safety and efficacy of this treatment method in improving local tumor control.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 16 to 80 with confirmed thymic epithelial tumors that have pleural spread or recurrence.

Not a fit: Patients with thymic tumors that do not have pleural spread or those with other types of malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced thymic tumors, potentially improving their prognosis.

How similar studies have performed: While the use of hyperthermic chemotherapy is established in other contexts, this specific application for thymic tumors is relatively novel and has not been extensively tested.

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.

Where this trial is running

Shanghai

• Shanghai Zhongshan Hospital — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Jianyong Ding, MD

Conditions: Thymic Epithelial Tumor, Hyperthermic Intrathoracic Chemotherapy, Thymic Epithelial Malignancies