The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train.
Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma
About this trial
This is an interventional treatment trial for Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma focused on measuring nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation, CEP (cisplatin, epirubicin,cyclophosphamide), thymoma
Eligibility Criteria
Inclusion Criteria: 18-75 years; Histological or cytological confirmed stage Ⅲ and Ⅳa thymoma; PET/CT or CT/MRI with at least one objectively measurable or evaluable lesion; Life expectancy >12months; ECOG PS 0-1; --Patients with thymoma metastasis; No found the other malignant tumors (expect has been controlled Carcinoma in situ of the cervix and Basal Cell Carcinoma); Informed consent was signed before the study began; Normal Bone marrow hematopoiesis and renal function,Blood routine: absolute neutrophil count≥1,500/uL,Hb>8.0g/dL,PLT>80×10*9/L,AST≤ 1.5 times the upper limit of normal,TBIL ≤1.5 times the upper limit of normal,calculated creatinine clearance ≤110µmol/L,blood urea nitrogen≤7.1mmol/L; Cardiac function: LVEF≥55%; Patients who have not active bleeding or coagulopathy before enrollment; Exclusion Criteria: -Patients who have been found thymoma metastasis; Patients with uncontrolled lung disease, Serious infection,active peptic ulcers, coagulation diaorders, Uncontrolled severe diabetes, connective tissue diseases or Bone marrow suppression and Induction therapy for intolerance; Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE version 5.0 ); Significant organ dysfunction: such as respiratory failure, NYHA classification Class III or IV, chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure(SBP> 180 mmHg or DBP> 100mmHg); Pregnant and lactating women; patients without undergo preoperative puncture biopsy or induction therapy; Patients with active uncontrollable neurological, mental disease or mental disorder, poor compliance, unable to cooperate and describe the treatment response; Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study; Known HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded; Patients with uncontrollable Stable myasthenia gravis or uncontrollable Serious autoimmune disease such as fulminant DIC; Patients who are known to be allergic or intolerant to chemotherapy drugs; severe-trauma; Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;
Sites / Locations
- Yian Zhang
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
CEP
NAB-Paclitaxel
Cisplatin was administered as 50 mg/m2 IV infusion on Day 1; Epirubicin was administered as 75 mg/m2 IV infusion on Day 1; Cyclophosphamide was administered as 500 mg/m2IV infusion on Day 1 of each 3-week cycle.Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.
NAB-Paclitaxel will be administered as 125 mg/m2 IV infusion on Day 1 、Day8 of each 3-week cycle. Cisplatin will be administered as 75 mg/m2 IV infusion on Day 1 of each 3-week cycle. Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.