Thymic Epithelial TumorNCT07328074
Electrocautery Resection Combined With HITHOC for Thymic Epithelial Tumors With Pleural Metastasis
An observational study of Thymic Epithelial Tumor and Thymoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Thymic Epithelial Tumor, Thymoma, Thymic Carcinoma
- What is being tested?
- 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 and Hyperthermic Intrathoracic Chemotherapy (HITHOC)
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Feb 2031
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital, Department of Thoracic Surgery
Shanghai, Shanghai Municipality, 200080
About this study
Official title: 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
Read more
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
- Being tested
- 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, Hyperthermic Intrathoracic Chemotherapy (HITHOC)
- Keywords
- Hyperthermic Intrathoracic Chemotherapy, HITHOC, Electrocautery, Cisplatin, Doxorubicin
- Medical subject headings
- Thymic epithelial tumor, Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 hyperthermicProcedure or surgery
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.
Hyperthermic Intrathoracic Chemotherapy (HITHOC)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Rate of grade ≥3 adverse events according to Clavien-Dindo classification related to surgery or chemotherapy. This includes surgical complications and chemotherapy-related toxicities.
Measured: From treatment initiation through 30 days post-treatment
Overall Survival (OS)
Time from disease grouping to death from any cause.
Measured: From enrollment to death from any cause, assessed up to 36 months
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.
Measured: Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic Epithelial TumorStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Fan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328074
- Sponsor's protocol ID
- 20250519101831997
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Electrocautery Resection Combined With Hyperthermic Intrathoracic Chemotherapy for Thymic Epithelial Tumors With Pleural Metastasis
- ClinicalTrials.gov ID
- NCT07328074
- Acronym / sponsor ID
- 20250519101831997
- Conditions
- Thymic Epithelial Tumor, Thymoma, Thymic Carcinoma, Pleural Metastasis, Pleural Recurrence
- Keywords
- Hyperthermic Intrathoracic Chemotherapy, HITHOC, Electrocautery, Cisplatin, Doxorubicin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrocautery Resection + HITHOC | – | 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)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. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 hyperthermicExtended 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 or surgery | Electrocautery Resection + HITHOC |
| 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. | Procedure or surgery | Electrocautery Resection + HITHOC |
Primary outcome
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.
3 secondary outcomes
Incidence of Grade ≥3 Treatment-Related Adverse Events
Time frame: 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
Quality of Life Assessed by EQ-5D
Time frame: Baseline, post-treatment, and at 3, 6, 12, 24, and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thymic Epithelial Tumor and Thymoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: From treatment initiation to first event (local recurrence, distant metastasis, or death), assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.