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.

Conditions: Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma

Summary: this study for a single-center prospective phase ii randomized controlled train to assess the efficacy and safety of induction therapy on thymoma .methods patients with thymoma (stage ⅲ and stage ⅳa) were treated with 2 cycles of (nab)-paclitaxel plus cisolation (paclitaxel for injection(aalbumin bound）125 mg/m2 day 1 、day8 ,cisplatin 75 mg/m2 day 1of each 3-week cycle）or cep(cisplatin 50 mg/m2 day 1, epirubicin 75 mg/m2 day 1,cyclophosphamide 500 mg/m2 day 1 of each 3-week cycle). following chemotherapy to evaluate the patient for operation. patients without undergo surgery will be continued to receive 2 cycles of primary chemotherap.


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；

Keywords: nanoparticle albumin-bound (nab)-paclitaxel plus cisolation cep (cisplatin, epirubicin,cyclophosphamide) thymoma