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Electrocautery Resection Combined With HITHOC for Thymic Epithelial Tumors With Pleural Metastasis

NCT07328074 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-02-05

No results posted yet for this study

Summary

The goal of this observational study is to explore the effectiveness of electrocautery resection combined with hyperthermic intrathoracic chemotherapy (HITHOC) in patients with thymic epithelial tumors with pleural metastasis or recurrence. The study aims to:

* Evaluate whether this combined treatment improves event-free survival in patients with pleural metastasis from thymic epithelial tumors
* Assess the rates of grade ≥3 treatment-related adverse events
* Examine how this treatment affects patients' quality of life

Participants will:

* Undergo extended thymectomy with electrocautery resection of pleural metastases
* Receive two cycles of hyperthermic intrathoracic chemotherapy with cisplatin and doxorubicin at 42-43°C, 2-4 days apart
* Complete quality of life questionnaires (EQ-5D) at baseline and regular intervals
* Have regular follow-up visits with imaging and clinical assessments for up to 36 months to monitor for disease recurrence or progression

Conditions

  • Thymic Epithelial Tumor
  • Thymoma
  • Thymic Carcinoma
  • Pleural Metastasis
  • Pleural Recurrence

Interventions

PROCEDURE

Patients with thymic epithelial tumors with pleural metastasis or recurrence who undergo extended thymectomy with electrocautery resection of pleural metastases followed by two cycles of hyperthermic

Extended thymectomy with electrocautery ablation and resection of pleural metastases. Larger lesions (\>1cm) are thoroughly ablated with electrocautery followed by complete resection. Smaller lesions (≤1cm) that are difficult to resect are thoroughly ablated with electrocautery.

PROCEDURE

Hyperthermic Intrathoracic Chemotherapy (HITHOC)

Two cycles of hyperthermic intrathoracic chemotherapy performed 2-4 days apart using BR-TRG-I device. Chemotherapy solution containing cisplatin (50 mg/m²) and doxorubicin (25 mg/m²) is circulated at 400 mL/min with inflow temperature maintained at 42-43°C for 60 minutes per cycle.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2031-02-28
Completion
2031-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07328074 on ClinicalTrials.gov