Thymic Epithelial Tumors
Conditions
Interventions
Thymoma:Tislelizumab in combination with chemotherapy
Thymic Carcinoma:Tislelizumab in combination with chemotherapy
Sponsors
Department of Oncology, The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Be = 18 and =75 years of age on day of signing informed consent. 2.Understand the steps and content of the study and voluntarily sign written informed consent 3.Have a histologically or cytologically confirmed diagnosis of unresectable thymoma or thymic carcinoma. 4.Have measurable disease based on RECIST 1.1. 5.Patients must not have had prior systemic anti-cancer therapy for locally advanced or metastatic unresectable thymoma or thymic carcinoma. 6.Have a performance status (PS) of 0 or 1 on the ECOG PS. 7.Life expectancy > 3 months. 8.Demonstrate adequate organ function as defined below all screening labs should be performed. ?Hematological: absolute neutrophil count = 1500/mcL; platelets = 80000mcL; hemoglobin = 9g/dL or = 5.6 mmol/L without transfusion within 4 weeks. ?Renal: serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) = 1.5 X upper limit of normal (ULN) OR = 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN. ?Hepatic: serum total bilirubin = 1.5 X ULN OR direct bilirubin = ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) = 2.5 X ULN OR = 5 X ULN for subjects with liver metastases; albumin = 2.5mg/dL. ?Doppler ultrasound assessment: Left Ventricular Ejection Fraction (LVEF) 9.Weight over 40kg, or BMI > 18.5 10.Female subject of childbearing potential should have a negative urine or serum pregnancy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.Male patients must also agree to use contraception during the study and for 6 months after the study ends
Exclusion criteria
Exclusion criteria: 1.Has a known additional malignancy past. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 2. Patients using other investigational drugs simultaneously. 3.Has a history of bleeding, any bleeding event with a severe grade of 3 degrees or higher in CTCAE 5.0 occurred within 4 weeks prior to screening 4.Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline).For patients with clinically suspected CNS metastasis, a CT or MRI examination must be performed within 28 days prior to admission to the cohort, excluding CNS metastasis 5.Patients with any severe and/or uncontrollable diseases, including: a) Poorly controlled blood pressure (systolic blood pressure = 140 mmHg, diastolic blood pressure = 90 mmHg); b) History of grade I or higher myocardial ischemia or myocardial infarction, arrhythmias (including QTc = 450ms in males, QTc = 470ms in females), and = Grade 2 congestive heart failure (New York Heart Association [NYHA] classification); 6.Patients who have undergone major surgery or experienced severe traumatic injury, fractures, 7.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 8.Patients with abnormal coagulation function and bleeding tendency 9.Urine analysis showing urine protein =++, and confirmed 24-hour urine protein quantification > 1.0 g. 10.Patients who have experienced venous or arterial thromboembolic events within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic attacks), deep venous thrombosis, and pulmonary embolism. 11. Active autoimmune diseases requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) before the first dose, including but not limited to myasthenia gravis, pure red cell aplasia, hypogammaglobulinemia, systemic lupus erythematosus, psoriasis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Replacement therapy (e.g., thyroid hormones, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment. 12.Severe hypersensitivity reactions following administration of other monoclonal antibodies. 13.Hypersensitivity to human or murine monoclonal antibodies. 14.As known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 15.Has Pleural or abdominal effusion with clinical symptoms requiring clinical intervention 16.Patients who do not comply with medical advice, do not take prescribed medications, or have incomplete information that can affect the judgment of efficacy or safety 17.At the investigator's discretion,Patients had concomitant medical conditions that seriously compromised patient safety or prevented patients from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactWen Gao
Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Outcome results
None listed