Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence

NCT ID: NCT05446935

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-11-30

Brief Summary

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

Thymic Epithelial Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HITOC

HITOC group contains all patients who undergo HIROC in this study.

Group Type: OTHER

HITOC

Intervention Type: PROCEDURE

Doxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2).

Interventions

HITOC

Doxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Zhongshan Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianyong Ding, MD

Role: CONTACT

ding.jianyong@zs-hospital.sh.cn

18616881268

Facility Contacts

Jianyong Ding, MD

Role: primary

References

Wang 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.

Reference Type: DERIVED

PMID: 40467556 (View on PubMed)

Yang 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.

Reference Type: DERIVED

PMID: 38410567 (View on PubMed)

Other Identifiers

B2021-703R

Identifier Type: -

Identifier Source: org_study_id