ClinicalTrials.gg
Not yet recruitingNCT07383142Updated Feb 6, 2026

Intrathoracic Chemotherapy for TETs With Pleural Spread or Recurrence (CHOICE-2)

An interventional study of Surgery alone and Surgery+HITOC in Thymic Epithelial Tumor, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Hyperthermic intrathoracic chemotherapy (HITOC) offers a strategy to eliminate microscopic residual disease after surgical resection. Especially it is investigated to improve long-term survival in thymic epithelial tumors with pleural dissemination or recurrence. A prospective, multicenter, randomized phase III clinical trial (CHOICE-2) is conducted to compare the efficacy and safety of surgery combined with HITOC versus surgery alone. The HITOC regimen involves intrathoracic perfusion with doxorubicin on postoperative day 1 and cisplatin on postoperative day 2.

Read the detailed description

Thymic epithelial tumors (TETs) frequently manifest with or recur as pleural dissemination (Stage IVa), presenting a significant clinical challenge. Although cytoreductive surgery is the cornerstone of treatment, achieving complete elimination of microscopic residual disease remains difficult, often leading to subsequent recurrence. Hyperthermic intrathoracic chemotherapy (HITOC) has emerged as a promising adjuvant strategy to control local disease by combining the cytotoxic effects of chemotherapy with hyperthermia to eradicate microscopic residuals.

Building on the favorable safety and efficacy results from the Phase II CHOICE study, the CHOICE-2 study is a prospective, multicenter, randomized, phase III clinical trial designed to compare surgery combined with HITOC versus surgery alone. A total of 202 eligible participants with pleural dissemination or pleural recurrence of TETs will be randomized in a 1:1 ratio into two arms.

Participants in the experimental arm will undergo lung-preserving cytoreductive surgery (pleurectomy/decortication or extended pleurectomy/decortication) followed by HITOC. The HITOC regimen involves intrathoracic perfusion with doxorubicin (25 mg/m²) on postoperative day 1 and cisplatin (50 mg/m²) on postoperative day 2, utilizing a perfusion system heated to 43°C for 60 minutes. Participants in the control arm will receive the same standard surgical resection without HITOC.

The primary objective is to evaluate the 3-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), myasthenia gravis (MG) remission rates according to MGFA criteria, and the incidence of perioperative complications.

02

Conditions studied

  • Thymic Epithelial Tumor

Keywords

  • Hyperthermic Intrathoracic Chemotherapy
03

In context

Thymic epithelial tumor

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

This study's planned enrollment of 202 is above the median of 48 across 19 interventional studies indexed under Thymic epithelial tumor.

Browse Thymic epithelial tumor studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  1. Age range: 18-75 years old; Expected survival time > 12 months; Preoperative imaging (CT, MRI, or PET-CT) clinically diagnosed as TETs
  2. Patients with de novo stage IVa thymoma (DNT) diagnosed by the multidisciplinary team (MDT) are eligible if deemed suitable for surgery under any of the following conditions: (1) candidates for primary surgery without ; (2) candidates for staged surgery who have completed phase I surgery and are reassessed by the MDT as eligible for phase II surgery 3 months postoperatively; or (3) patients initially requiring induction therapy, provided the diagnosis is confirmed by , induction therapy is administered according to TET guidelines, imaging and laboratory evaluations are performed 4-6 weeks after completion of therapy, and the MDT confirms the absence of surgical contraindications upon re-evaluation.
  3. For patients with thymoma with pleural recurrence (TPR), the initial surgery must have achieved complete resection without evidence of pleural dissemination or intraoperative tumor rupture, and the interval between the first surgery and the development of pleural must be longer than 6 months.
  4. According to the definition of T1-3NxM1a stage, no intrapericardial dissemination, no intrapulmonary parenchymal metastatic nodules, no distant organ metastasis (M1b)
  5. During the operation, the pleural nodules were removed. The frozen section pathology during the operation confirmed that the pleural nodules were TETs pleural metastatic nodules.
  6. No history of other malignant tumors, except for patients who had prior treated with curative surgery, were confirmed to have pathologic stage I disease requiring no therapy (e.g., resected pulmonary ground-glass opacity or papillary thyroid carcinoma) and have remained free of recurrence for more than 5 years.
  7. ASA stage I/II
  8. Be able to understand the situation of this study and sign the form.

Exclusion criteria

Exclusion Criteria:

  1. Preoperative imaging examinations such as CT, MRI or PET-CT, or intraoperative exploration revealed that the tumor involved the ascending aorta, aortic arch, descending aorta, intrapericardial pulmonary vessels, heart, trachea or esophagus (T4), or had dissemination within the pericardium (M1a) or hematogenous (M1b stage);
  2. Within 4-6 weeks after completion of induction therapy (chemotherapy, radiotherapy, immunotherapy, or targeted therapy), imaging studies (CT or PET-CT) and laboratory evaluations (complete blood count, liver and renal function, cardiac biomarkers, and thyroid function) were performed by the mediastinal MDT to assess surgical eligibility; patient found to have surgical and deemed unsuitable for surgery or HITOC were excluded;
  3. The diagnosis was confirmed by or puncture as a non-TETs type (such as lymphoma, neurogenic tumor, germ cell tumor, thymic lipoma, thymic sarcoma or neuroendocrine tumor);
  4. The patient had a history of multiple surgeries in the past (≥2), the initial surgery of TPR was palliative resection, and pleural dissemination was a iatrogenic implantation site; or the patient received a radiotherapy dose greater than 60 Gy before enrollment;
  5. Had other active malignant tumors, or had received anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy, small molecule targeted therapy or other anti-tumor biological agents) for other malignant tumors in the past;
  6. The patient had myasthenia gravis in an unstable state or during an acute exacerbation;
  7. Had the following major cardiovascular disease histories: congestive heart failure, poorly controlled angina pectoris, transmural myocardial infarction, high-risk arrhythmia, significant valvular disease or poorly controlled hypertension, cardiovascular compensatory dysfunction;
  8. The patient had a weight loss of more than 5 kg within the past one month; severe uncontrolled systemic systemic diseases, such as active infection or poorly controlled diabetes; patients with bleeding disorders and those with bleeding tendencies; patients with abnormal coagulation function, with bleeding tendencies or undergoing thrombolysis or anticoagulation treatment; patients with grade II-IV bone marrow suppression;
  9. The patient had a history of thoracic surgery due to tuberculous pleurisy or mesothelioma, and the contralateral lung atrophy involved one or more lung lobes or more than one lung lobe;
  10. The patient had an allergy history to cisplatin or doxorubicin drugs;
  11. Had a history of organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation); Had a history of mental disorders, neurological diseases or other central nervous system diseases affecting compliance;
  12. The patient was in the acute inflammatory stage due to bacterial, viral or other pathogenic microorganism infection; Had active infection of immunodeficiency virus (), virus (HBV) or virus (HCV) or known HIV seropositivity;
  13. Pregnant or lactating women, and fertile men and women who were unwilling to use adequate measures during treatment;
  14. The patient had received grade IV surgical treatment within 2 months or was in a recovery state due to other diseases or was in the intervention period of other research projects.
Terms in these criteria, in plain language(12)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

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

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.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

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.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
202 participants (estimated)

Study arms

  • Active comparator
    Surgery alone

    Procedure: Surgery alone

  • Experimental
    Surgery+HITOC

    Procedure: Surgery+HITOC

Interventions

  • ProcedureSurgery alone

    Patients undergo lung-preserving cytoreductive surgery, including pleurectomy/decortication (P/D) or extended pleurectomy/decortication (eP/D), via video-assisted thoracoscopic surgery (VATS) or thoracotomy. The goal is to achieve macroscopic complete resection of all visible pleural nodules and involved structures (e.g., pericardium, diaphragm). Extrapleural pneumonectomy (EPP) is excluded from the surgical strategy.

  • ProcedureSurgery+HITOC

    Patients undergo the same cytoreductive surgery (P/D or eP/D) as the control group. Following surgery, patients receive hyperthermic intrathoracic chemotherapy (HITOC) using a hyperthermic perfusion system heated to 43°C. The regimen consists of intrathoracic perfusion with doxorubicin (25 mg/m²) on postoperative day 1 (POD 1), followed by intrathoracic perfusion with cisplatin (50 mg/m²) on postoperative day 2 (POD 2).

06

What researchers measure

Primary outcomes

  1. 3-year progression-free survival (PFS)

    Time frame: The 3-year PFS is defined as the proportion of patients who are alive and have not experienced disease progression at 3 years after surgery.

Secondary outcomes

  1. 3-year overall survival (OS)

    Time frame: The 3-year OS is defined as the proportion of patients who are alive at 3 years after surgery, regardless of disease status or cause of death.

  2. Myasthenia gravis remission rate (MGFA criteria)

    The proportion of participants with myasthenia gravis (MG) achieving "Overall Remission" assessed according to the Myasthenia Gravis Foundation of America (MGFA) Post-Intervention Status Classification. As per the study protocol, overall remission is defined as the sum of patients achieving complete stable remission (CSR), pharmacologic remission (PR), or minimal manifestation status (MMS).

    Time frame: The MG remission rate is calculated at the last follow-up in the three years after surgery.

  3. Grade ≥3 complications (Clavien-Dindo, 5th ed.)

    The complication rate was calculated at 1 month after surgery

    Time frame: 1 month postoperatively

  4. Quality of life (EORTC QLQ-C30) at 1 month

    Time frame: 1 month postoperatively

  5. Quality of life (EORTC QLQ-C30) at 3 months

    Time frame: 3 months postoperatively

  6. Quality of life (EORTC QLQ-C30) at 6 months

    Time frame: 6 months postoperatively

  7. Perioperative myasthenic crisis incidence

    Postoperative Myasthenic Crisis (POMC) is defined as respiratory failure caused by myasthenia gravis (MG) requiring immediate intubation and total postoperative ventilatory support for more than 24 hours or requiring re-intubation and ventilatory support within 30 days after extubation. The POMC rate was calculated at 1 month after surgery.

    Time frame: 1 month postoperatively

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2026; primary completion for Feb 2029, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2026
First posted
Feb 3, 2026
StartEst.
Feb 1, 2026
Primary completionEst.
Feb 1, 2029
CompletionEst.
Feb 1, 2032
Last update
Feb 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07383142
Collaborators
Sir Run Run Shaw Hospital, West China Hospital, Liaoning Cancer Hospital & Institute, Fujian Medical University Union Hospital, Qilu Hospital of Shandong University, Jiangxi Provincial People's Hopital, Zhongshan Hospital (Xiamen), Fudan University, Tang-Du Hospital, Xuhui Central Hospital, Shanghai
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Feb 1, 2029 (estimated)
Completion
Feb 1, 2032 (estimated)
Last update
Feb 6, 2026

Study contacts

Jianyong Ding
Contact
ding.jianyong@zs-hospital.sh.cn
+86 18616881268

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 Feb 2026. You cannot join it, but the record below documents what was studied.

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