thymoma
Conditions
Interventions
Experimental group:surgery, intra-operative hyperthermic intrathoracic chemotherapy, and post-operative entire hemi-thoracic radiotherapy
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Be able to understand and voluntarily sign a written ICF; (2) Male or female aged 18-75 years (including 18 and 75 years); (3) thymoma confirmed by pathology; (4) If the mediastinal primary lesion is present, the primary lesion should be potentially resectable (T1-3); (5) Patients with unilateral pleural disease, including patients with mediastinal primary lesion combined with pleural disease and pleural recurrence after resection of mediastinal primary tumor. The pleural lesions need to be pathologically confirmed as thymoma or neoplastic lesions (that is, benign pleural thickening and other possibilities are excluded), which can be detected by preoperative biopsy or intraoperative rapid freezing pathology. (6) had not received pleural radiotherapy before; a) Patients who can tolerate surgery, chemotherapy, and radiotherapy. (7) Have at least one measurable lesion that meets the RECIST 1.1 criteria. (8) Vital organ function must meet the following criteria: a) Blood routine examination: (no blood transfusion, no use of G-CSF and other cytogenic drug correction treatment within 2 weeks before screening); b) Hemoglobin (HB) >=90 g/L; c) Neutrophil count absolute value (ANC) >=1.5×109/L; d) Platelet count (PLT) >=90×109/L; e) White blood cell count (WBC) >=3.0×109/L and =30 g/L; d) Creatinine (Cr) =50mL/min (Cockcroft-Gault formula); e) Activated partial thromboplastin time (APTT) =50%.
Exclusion criteria
Exclusion criteria: (1) Patients with thymic carcinomas or thymic neuroendocrine neoplasms were excluded (2) Patients with bilateral pleural diseases were excluded; (3) If there was a primary mediastinal lesion, patients with unresectable primary lesions were excluded (T4); (4) Patients who had received pleural radiotherapy were excluded; (5) Patients with distant metastasis were excluded; b) The presence of any clinically significant systemic disease that the investigator determines requires treatment; (6) Known or suspected allergy to the investigational drug; (7) Pregnant or lactating female patients; (8) In the treatment period of other interventional clinical trials within 4 weeks before the first dose; Participants in non-interventional clinical trials (e.g. epidemiological studies) are eligible for inclusion in this study; If you are in the survival follow-up period of the interventional clinical trial, you can also be enrolled in this study; (9) In the investigator's opinion, the patient has any instability or any disease or medical condition that may affect his safety or study compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3y-PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| CIR for pleural disease;OS;adverse event;Perioperative complications; | — |
Countries
China
Contacts
Public ContactTeng Mao
Shanghai Chest Hospital
Outcome results
None listed