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Not yet recruitingNCT07328074Updated Feb 5, 2026

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

An observational study in Thymic Epithelial Tumor, Thymoma and Thymic Carcinoma, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
16 Years to 80 Years
Sex
All
01

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
02

Conditions studied

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

Keywords

  • Hyperthermic Intrathoracic Chemotherapy
  • HITHOC
  • Electrocautery
  • Cisplatin
  • Doxorubicin
03

In context

Thymic epithelial tumor

26 studies on the registry are indexed under Thymic epithelial tumor; 19 are open to participants now.

Browse Thymic epithelial tumor studies →

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • (ASA) physical status classification I-II
  • Normal major organ function
  • No history of other
  • 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

Exclusion criteria

Exclusion Criteria:

  • Evidence of extrathoracic 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 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • ProcedurePatients 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.

  • ProcedureHyperthermic 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Incidence of Grade ≥3 Treatment-Related Adverse Events

    Rate of grade ≥3 adverse events according to Clavien-Dindo classification related to surgery or chemotherapy. This includes surgical complications and chemotherapy-related toxicities.

    Time frame: From treatment initiation through 30 days post-treatment

  2. Overall Survival (OS)

    Time from disease grouping to death from any cause.

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

  3. Quality of Life Assessed by EQ-5D

    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.

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

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07328074
Responsible party
Jiang Fan (Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Jan 8, 2026
Start date
Feb 2026 (estimated)
Primary completion
Feb 2031 (estimated)
Completion
Feb 2031 (estimated)
Last update
Feb 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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