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

February 2, 2026 updated by: Jiang Fan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Prospective Cohort Study of Electrocautery Resection Combined With Hyperthermic Intrathoracic Chemotherapy for Thymic Epithelial Tumors With Pleural Metastasis

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
        • Shanghai General Hospital, Department of Thoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade ≥3 Treatment-Related Adverse Events
Time Frame: From treatment initiation through 30 days post-treatment
Rate of grade ≥3 adverse events according to Clavien-Dindo classification related to surgery or chemotherapy. This includes surgical complications and chemotherapy-related toxicities.
From treatment initiation through 30 days post-treatment
Overall Survival (OS)
Time Frame: From enrollment to death from any cause, assessed up to 36 months
Time from disease grouping to death from any cause.
From enrollment to death from any cause, assessed up to 36 months
Quality of Life Assessed by EQ-5D
Time Frame: Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months
Quality of life assessed using the EuroQol 5 Dimensions (EQ-5D) questionnaire. The EQ-5D visual analog scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better quality of life.
Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250519101831997

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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