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

NCT07328074 | Not Yet Recruiting

• 1 other identifier: 20250519101831997
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyperthermic Intrathoracic Chemotherapy; HITHOC; Electrocautery; Cisplatin; Doxorubicin

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival (EFS)

  Time from treatment start to first occurrence of local recurrence, distant metastasis, or death from any cause. Events are assessed through regular imaging and clinical follow-up.

  From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months

Secondary Outcomes (3)

• Incidence of Grade ≥3 Treatment-Related Adverse Events

  From treatment initiation through 30 days post-treatment

• Overall Survival (OS)

  From enrollment to death from any cause, assessed up to 36 months

• Quality of Life Assessed by EQ-5D

  Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months

Study Arms (1)

Electrocautery Resection + HITHOC

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 intrathoracic chemotherapy (HITHOC) with cisplatin and doxorubicin.

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; Procedure: Hyperthermic Intrathoracic Chemotherapy (HITHOC)

Interventions

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 PROCEDURE

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.

Electrocautery Resection + HITHOC

Hyperthermic Intrathoracic Chemotherapy (HITHOC) PROCEDURE

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.

Electrocautery Resection + HITHOC

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 16-80 years with pathologically confirmed thymic epithelial tumors (thymoma or thymic carcinoma) with pleural dissemination or recurrence, suitable for electrocautery resection and hyperthermic intrathoracic chemotherapy as determined by multidisciplinary team.

You may qualify if:

• Pathologically confirmed thymic epithelial tumor (TET)
• Imaging evidence of thymic epithelial tumor with pleural dissemination or recurrence, deemed suitable for HITHOC by multidisciplinary thoracic team
• Age ≥16 years and ≤80 years
• American Society of Anesthesiologists (ASA) physical status classification I-II
• Normal major organ function
• No history of other malignancies
• Prior chemotherapy completed \>4 weeks, radiotherapy \>6 weeks, immunotherapy \>6 weeks before enrollment
• No allergy to cisplatin or doxorubicin
• Able to understand the study content and provide informed consent

You may not qualify if:

• Evidence of extrathoracic metastasis on imaging or pathological examination
• Myasthenia gravis in unstable phase or acute exacerbation
• Severe systemic comorbidities, such as active infection, poorly controlled diabetes, coagulopathy, bleeding tendency, or ongoing thrombolytic/anticoagulation therapy
• Positive serum pregnancy test or lactation (females)
• History of organ transplantation (including autologous bone marrow transplantation and peripheral blood stem cell transplantation)
• History of peripheral nervous system disease, significant psychiatric disorder, or central nervous system disease
• Currently participating in other clinical trials

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital, Department of Thoracic Surgery

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Thymic epithelial tumor; Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: February 5, 2026

Record last verified: 2025-12

Locations

CN (1)