thymoma
Conditions
Interventions
Test group:methylprednisolone/prednisone
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a) Be able to understand and voluntarily sign a written ICF; b) Male or female aged 18-75 years; c) Pathological confirmation of thymoma with type B component (type AB/B); d) Patients with SD/PD after first-line chemotherapy induction or tumors still unable to be resected or unable to tolerate the toxicity of chemotherapy; e) UICC stage III-IVa potentially unresectable tumors; f) tumors that cannot be treated with definitive radiotherapy.
Exclusion criteria
Exclusion criteria: a) Previous induction chemotherapy regiments containing glucocorticoid; b) Patients with myasthenia receiving glucocorticoid therapy (except those who receive glucocorticoid therapy for less than one month at a dose of less than 0.75mg/kg); c) with other autoimmune diseases; d) Receiving other tumor-related treatments in addition to chemotherapy (including targeting, immunization, and radiotherapy); e) Cases of bilateral pleural metastasis; f) distant metastasis; g) Poor blood sugar control; h) Diseases of the cardiovascular system meet any of the following criteria: i. Congestive heart failure with cardiac function =NYHA Class II; ii. Arrhythmias poorly controlled by drugs; iii. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass grafting occurred within 6 months prior to initial administration; iv. Left ventricular ejection fraction (LVEF) < 50%; i) High blood pressure that cannot be controlled by medication; j) 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; k) There is an active bacterial, fungal, or viral infection that requires systemic treatment within 1 week prior to initial dosing; l) 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; m) 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.); n) The presence of any clinically significant systemic disease that the investigator determines requires treatment; o) The presence of poorly healed wounds, severe ulcers, fractures or osteonecrosis; p) Known or suspected allergy to the investigational drug; q) Pregnant or lactating female patients; r) in the treatment phase of other interventional clinical trials within 4 weeks prior to initial administration; 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; s) 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 |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of surgery;pathological response;adverse event;progression free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWENTAO FANG
Shanghai Chest Hospital
Outcome results
None listed