A Clincal Trial of Apatinib Mesylate and Etoposide(VP-16) as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low. There is no standard maintenance treatment recommendation for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical trial is designed to investigate the efficacy and safety of apatinib combine with etoposide as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of extensive-stagesmall cell lung caner(SCLC) ,after first-line therapy
- •Performance status of 0～2 on the ECOG criteria
- •Expected survival is above three months
- •Adequate hematologic (neutrophil count>=1.5×109/L, hemoglobin>=80g/L, platelets>=80×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x2, bilirubin level =< UNL x 1.5)
- •Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
排除标准
- •suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- •Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
- •Bleeding tendency or coagulation disorders.
- •Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- •Urine protein≥++, or urine protein in 24 hours≥2.0g.
- •severe uncured wounds, ulcers or fracture.
- •Pregnant or breast-feeding.
- •Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- •The researcher believe that the Patient is not suitable to participate in the study.
研究组 & 干预措施
Apatinib, Etoposide
Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .
干预措施: Apatinib, Etoposide (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 6 months
The first day of treatment to the date that disease progression is reported
次要结局
- Overall survival(up to 24 months)
- Duration of Response(up to 24 months)
- Tumor response rate(Time Frame: 3 month)
- Quality of Life (QoL) questionnaire(up to 24 months)
研究者
xionghong cai
epartment of Medical Oncology, Sichuan Cancer Hospital & Institute, Chengdu, Sichuan, PR China
Sichuan Cancer Hospital and Research Institute