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.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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；
排除标准
- •-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；
研究组 & 干预措施
CEP
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.
干预措施: Cisplatin plus Epirubicin plus Cyclophosphamide (Drug)
NAB-Paclitaxel
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.
干预措施: NAB-Paclitaxel plus Cisplatin (Drug)
结局指标
主要结局
overall response rate (ORR)
时间窗: assessed up to 1 year
the proportion of patients with complete response and partial response , using RECIST v 1.1
次要结局
- Incidence of adverse events(assessed up to 1 year)
- Main pathological Response(assessed up to 1 year)
- 3-year disease free survival (3yr-DFS)(assessed up to 3 year)
- Surgical conversion success rate(assessed up to 1 year)
- overall survival rate (OS)(assessed up to 3 year)
- Pathologic Complete Response（pCR）(assessed up to 1 year)
研究者
Peng Liu
Director
Shanghai Zhongshan Hospital