Thymoma
Conditions
Interventions
Chemotherapy:Platinum-containing chemotherapy regimens CAP or TC, determined by the investigator, administered every 3 weeks for 2 cycles.
CAP regimen: Cisplatin 50 mg/m^2 IV on day 1
Doxorubicin 50 mg/m^2 IV on day 1
Cyclophosphamide 500 mg/m2 IV on day 1.
TC regimen: Carboplatin AUC 4-5
Paclitaxel 200 mg/m^2.
Glucocorticoid:Methylprednisolone 1g with 250ml normal saline, intravenous infusion, once daily, days 1-3, once a week, for 2 courses.
For patients with myasthenia gravis combined with severe disease
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. Pathologically confirmed type B thymoma; 4. The eighth UICC stage III-IVa potentially unresectable tumor; 5. Patients who have not received surgery, chemotherapy, radiotherapy, and other anti-tumor treatments; 6. Patients with PS score 0-1 who can tolerate chemotherapy, hormone therapy, surgery, 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: (1)Routine blood examination: (no blood transfusion, no G-CSF and other cytogenic drug correction treatment within 2 weeks before screening); (2)Hemoglobin (HB) >=90 g/L; (3)Absolute neutrophil count (ANC) >=1.5×10^9/L; (4)Platelet count (PLT) >=90×10^9/L; (5)White blood cell count (WBC) >=3.0×109/L and =30 g/L; (4)Creatinine (Cr) =50mL/min (Cockcroft-Gault formula); (5)Activated partial thromboplastin time (APTT) =50%.
Exclusion criteria
Exclusion criteria: 1. tumors with pathologic types including thymic carcinoma and other non-B thymoma components; 2. Patients with myasthenia receiving glucocorticoids (except those who have received glucocorticoids for less than one month at a dose of less than 0.75mg/kg); 3. with other autoimmune diseases; 4. have received other tumor-related treatments (including targeting, immunization, radiotherapy, surgery); 5. Cases of bilateral pleural metastases; 6. There is widespread distant metastasis; 7. Poor blood sugar control after drug treatment; 8. Diseases of the cardiovascular system meet any of the following criteria: (1). Congestive heart failure with cardiac function =NYHA Class II; (2) Arrhythmias poorly controlled by drugs; (3)Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass grafting occurred within 6 months prior to initial administration; (4)Left ventricular ejection fraction (LVEF) < 50%; 9. High blood pressure that cannot be controlled by medication; 10. hyperarterial/venous thrombotic events or embolic events, such as stroke (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration; 11. There is an active bacterial, fungal, or viral infection that requires systemic treatment within 1 week prior to initial dosing; 12. Active gastrointestinal ulcer, ulcerative colitis, intestinal obstruction and other conditions that researchers have determined may cause gastrointestinal bleeding or perforation; Or the past intestinal perforation, intestinal fistula treatment has not been cured; 13. have multiple factors that affect the absorption, distribution, metabolism or clearance of oral drugs (such as inability to swallow drugs, frequent vomiting, chronic diarrhea, etc.); 14. The presence of any clinically significant systemic disease that the investigator determines requires treatment; 15. The presence of poorly healed wounds, severe ulcers, fractures or osteonecrosis; 16. Known or suspected allergy to the investigational drug; Pregnant or lactating female patients; 17. in the treatment phase of other interventional clinical trials within 4 weeks prior to initial administration; 18. 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; 19. In the investigator's opinion, the patient has any instability or any disease or medical condition that may affect his or her safety or adherence to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical rate;Adverse event;PFS; | — |
Countries
China
Contacts
Public ContactTeng Mao
Shanghai Chest Hospital
Outcome results
None listed