Thymic Epithelial TumorCHOICENCT05446935
Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence
A study testing HITOC in people with Thymic Epithelial Tumor, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Hyperthermic intrathoracic chemotherapy (HITOC) offers an additional treatment option for malignant pleural tumors after surgical cytoreduction. Especially it is used to further improve local tumor control in thymic malignancies with pleural spread, who underwent multimodality therapy including surgical resection. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Thymic Epithelial Tumor
- What is being tested?
- HITOC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Puncture biopsy, thoracoscopic/mediastinal biopsy, or surgery to confirm pathologically thymic epithelial tumor (TETs)
- Imaging examination shows TETs with pleural spread or recurrence, and the mediastinal MDT team considers HITOC suitable.
- Patients with ≥16 and ≤80 years old.
- ASA I-II.
- The patients should have no functional disorders in the main organs.
- There was no history of other malignant carcinomas.
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- The duration from the last chemotherapy was >4 weeks, the duration from the last radiotherapy was >6 weeks, and the duration from the last immunotherapy was >6 weeks.
- Not allergic to cisplatin or doxorubicin.
- The patients should be able to understand our research and sign the informed consent.
Who cannot join
- Imaging or pathological examination shows TETs without pleural spread or recurrence, or with pericardial dissemination or extrathoracic metastasis.
- Patients with lymphoid system, neurogenic or reproductive system carcinoma.
- Patients who have been receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
- Patients with myasthenia gravis in unstable or acute exacerbation stage.
- The patients have been proven history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control.
- The patients have the severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under-treatment of thrombolysis or anticoagulant therapy.
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- Female who is positive for a serum pregnancy test or during lactation period.
- The patients have a history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation.
- The patients have a history of peripheral nerve system disorders, obvious mental disorders, or central nerve system disorders.
- The patients attend other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, 200032
Jianyong Ding, MD
About this study
Official title: Cytoreductive Surgery and Hyperthermic Intrathoracic Chemotherapy for the Treatment of Thymic Epithelial Malignancies With Pleural Spread or Recurrence (CHOICE): a Prospective, Open, Single-arm Study Choice
Hyperthermic intrathoracic chemotherapy (HITOC) offers an additional treatment option for malignant pleural tumors after surgical cytoreduction. Especially it is used to further improve local tumor control in thymic malignancies with pleural spread, who underwent multimodality therapy including surgical resection. A phase II clinical study was conducted to explore the efficacy and safety of surgery followed by HITOC (POD1: DOX, POD2: cisplatin) for thymic epithelial tumors with pleural spread or recurrence.
- Conditions
- Thymic Epithelial Tumor
- Being tested
- HITOC
- Keywords
- Hyperthermic Intrathoracic Chemotherapy, Thymic Epithelial Malignancies
- Medical subject headings
- Thymic epithelial tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITOCProcedure or surgery
Doxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2).
| Study group | Role | What they receive |
|---|---|---|
| HITOC | Other | HITOC group contains all patients who undergo HIROC in this study. Receives: Procedure: HITOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hospital stay
Postoperative hospital stay is the duration for every enrolled patient until the date of meeting the criteria of hospital discharge since the date of surgery.
The criteria of hospital discharge were defined as with the volume of postoperative drainage < 200 ml/day, a normal chest X-ray, and good physical condition.
Measured: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
treatment-related adverse events and complications
Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
EORTC QLQ-C30 score for overall quality of life
Overall quality of life is respectively evaluated at randomization and 1 month, 3 month, 6 month after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Scale (EORTC QLQ-C30) (V3.0).
The minimum value of EORTC QLQ-C30 score was 0， and the maximum was 100. Zero indicates the worst quality of life, while 100 represents the best quality of life.
Measured: Up to the end of follow-up since the date of randomization, up to 6 months.
Secondary outcomes (4)
Visual Analog Scales scores for postoperative pain
the cumulative daily pain score at rest using VAS from postoperative 0 to 72 hours. The minimum value of the VAS score was 0，and the maximum was 10. Zero indicates the least painful, while 1 represents the worst. The smaller (larger) cumulative daily pain score represents the less (more) pain.
Measured: from 0 to 72 hours after surgery
Volume of postoperative drainage
The volume of postoperative drainage of the patient was the sum of his daily drainage volume after the surgery. The types of drainage equipment include the thorax close drainage equipment and the unidirectional negative-pressure drainage ball.
Measured: Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days
Progression-free survival (PFS)
the duration from the date of S-HITOC to the date of the first progression. Disease progression is defined as locoregional (anterior mediastinal area, lung, pericardiac metastasis or pleural progression) or metastatic (supraclavicular lymph nodes or distant organs).
Measured: Through study completion, an average of 5 year
Overall survival (OS)
the duration from the date of S-HITOC to the date of the death.
Measured: Through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thymic Epithelial TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Prospective single-arm Study
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446935
- Sponsor's protocol ID
- B2021-703R
- Acronym
- CHOICE
- Status last verified
- Sep 2022
- First submitted
- 28 Jun 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang S, Yang X, Jiang J, Liang F, Zheng Y, Ao Y, Gao J, Wang H, Tan L, Ding J. Cytoreductive surgery and hyperthermic intrathoracic chemotherapy in thymic epithelial tumors with pleural spread or recurrence: a prospective, single-arm, phase II study. Nat Commun. 2025 Jun 4;16(1):5175. doi: 10.1038/s41467-025-60386-0.
PubMed 40467556Yang X, Wang S, Jiang J, Lin M, Gao J, Ding J, Tan L. Cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy for the treatment of thymic epithelial malignancies with pleural spread or recurrence (CHOICE): a study protocol for a prospective, open, single-arm study. J Thorac Dis. 2024 Jan 30;16(1):760-767. doi: 10.21037/jtd-23-759. Epub 2023 Dec 25.
PubMed 38410567
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreductive Surgery and Hyperthermic Intrathoracic Chemotherapy for the Treatment of Thymic Epithelial Malignancies With Pleural Spread or Recurrence (CHOICE): a Prospective, Open, Single-arm Study Choice
- ClinicalTrials.gov ID
- NCT05446935
- Acronym / sponsor ID
- CHOICE / B2021-703R
- Conditions
- Thymic Epithelial Tumor
- Keywords
- Hyperthermic Intrathoracic Chemotherapy, Thymic Epithelial Malignancies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 7 Jul 2022 (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.
Hyperthermic intrathoracic chemotherapy (HITOC) offers an additional treatment option for malignant pleural tumors after surgical cytoreduction. Especially it is used to further improve local tumor control in thymic malignancies with pleural spread, who underwent multimodality therapy including surgical resection. A phase II clinical study was conducted to explore the efficacy and safety of surgery followed by HITOC (POD1: DOX, POD2: cisplatin) for thymic epithelial tumors with pleural spread or recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Prospective single-arm Study
| Arm | Type | Receives |
|---|---|---|
| HITOC | Other | Procedure: HITOCHITOC group contains all patients who undergo HIROC in this study. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Puncture biopsy, thoracoscopic/mediastinal biopsy, or surgery to confirm pathologically thymic epithelial tumor (TETs)
- Imaging examination shows TETs with pleural spread or recurrence, and the mediastinal MDT team considers HITOC suitable.
- Patients with ≥16 and ≤80 years old.
- ASA I-II.
- The patients should have no functional disorders in the main organs.
Key exclusion criteria (10 listed)
- Imaging or pathological examination shows TETs without pleural spread or recurrence, or with pericardial dissemination or extrathoracic metastasis.
- Patients with lymphoid system, neurogenic or reproductive system carcinoma.
- Patients who have been receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
- Patients with myasthenia gravis in unstable or acute exacerbation stage.
- The patients have been proven history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control.
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 |
|---|---|---|
| HITOCDoxorubicin(dose: 25mg/m2) + Cisplatin(dose: 50mg/m2). | Procedure or surgery | HITOC |
Primary outcome
Postoperative hospital stay
Time frame: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
Postoperative hospital stay is the duration for every enrolled patient until the date of meeting the criteria of hospital discharge since the date of surgery. The criteria of hospital discharge were defined as with the volume of postoperative drainage < 200 ml/day, a normal chest X-ray, and good physical condition.
treatment-related adverse events and complications
Time frame: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0.
EORTC QLQ-C30 score for overall quality of life
Time frame: Up to the end of follow-up since the date of randomization, up to 6 months.
Overall quality of life is respectively evaluated at randomization and 1 month, 3 month, 6 month after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Scale (EORTC QLQ-C30) (V3.0). The minimum value of EORTC QLQ-C30 score was 0， and the maximum was 100. Zero indicates the worst quality of life, while 100 represents the best quality of life.
4 secondary outcomes
Visual Analog Scales scores for postoperative pain
Time frame: from 0 to 72 hours after surgery
Volume of postoperative drainage
Time frame: Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days
Progression-free survival (PFS)
Time frame: Through study completion, an average of 5 year
Overall survival (OS)
Time frame: Through study completion, an average of 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 40467556Wang S, Yang X, Jiang J, Liang F, Zheng Y, Ao Y, Gao J, Wang H, Tan L, Ding J. Cytoreductive surgery and hyperthermic intrathoracic chemotherapy in thymic epithelial tumors with pleural spread or recurrence: a prospective, single-arm, phase II study. Nat Commun. 2025 Jun 4;16(1):5175. doi: 10.1038/s41467-025-60386-0.
- Derived from this study: PubMed 38410567Yang X, Wang S, Jiang J, Lin M, Gao J, Ding J, Tan L. Cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy for the treatment of thymic epithelial malignancies with pleural spread or recurrence (CHOICE): a study protocol for a prospective, open, single-arm study. J Thorac Dis. 2024 Jan 30;16(1):760-767. doi: 10.21037/jtd-23-759. Epub 2023 Dec 25.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HITOC in people with Thymic Epithelial Tumor, run by Shanghai Zhongshan Hospital 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 10 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianyong Ding, MD (18616881268, ding.jianyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hospital stay (time frame: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446935, which also lists 2 linked publications.
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 19 Sep 2022.