Clinical trial · Interventional
Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence
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
NCT05446935CI-TRIAL-00060917CHOICEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Hyperthermic intrathoracic chemotherapy (HITOC) offers an additional treatment option for malignant pleural tumors after surgical cytoreduction. Especially it is used to further improve local tumor control in thymic malignancies with pleural spread, who underwent multimodality therapy including surgical resection. A phase II clinical study was conducted to explore the efficacy and safety of surgery followed by HITOC (POD1: DOX, POD2: cisplatin) for thymic epithelial tumors with pleural spread or recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymic Epithelial Tumor | Thymus Epithelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HITOC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- HITOC
- description
- HITOC group contains all patients who undergo HIROC in this study.
- interventionNames
- Procedure: HITOC
Primary outcomes (3)
- measure
- Postoperative hospital stay
- timeFrame
- Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
- description
- Postoperative hospital stay is the duration for every enrolled patient until the date of meeting the criteria of hospital discharge since the date of surgery. The criteria of hospital discharge were defined as with the volume of postoperative drainage \< 200 ml/day, a normal chest X-ray, and good physical condition.
- measure
- treatment-related adverse events and complications
- timeFrame
- Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDWang S, Yang X, Jiang J, Liang F, Zheng Y, Ao Y, Gao J, Wang H, Tan L, Ding J. Cytoreductive surgery and hyperthermic intrathoracic chemotherapy in thymic epithelial tumors with pleural spread or recurrence: a prospective, single-arm, phase II study. Nat Commun. 2025 Jun 4;16(1):5175. doi: 10.1038/s41467-025-60386-0. PMID 40467556
- DERIVEDYang X, Wang S, Jiang J, Lin M, Gao J, Ding J, Tan L. Cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy for the treatment of thymic epithelial malignancies with pleural spread or recurrence (CHOICE): a study protocol for a prospective, open, single-arm study. J Thorac Dis. 2024 Jan 30;16(1):760-767. doi: 10.21037/jtd-23-759. Epub 2023 Dec 25. PMID 38410567