S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer：An One-arm, Phase Ⅱ, Multi-center Clinical Study (SALTER TRIAL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one standard chemotherapy.
详细描述
Although SCLC is very responsive to initial treatment, most patients relapse with relatively resistant disease.These patients have a median survival of only 4 to 5 months when treated with further systemic therapy. Improvements in therapy for relapsed SCLC are much needed.The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one standard chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histological or cytologically confirmed small cell lung cancer;
- •Systemic chemotherapy that has previously received at least one or more lines regimen, followed by disease progression or recurrence;
- •Age 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
- •participants had at least one measurable target lesion by RECIST1.1
- •The main organ function meets the following criteria:absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥80 × 109 / L, hemoglobin ≥ 80 g / L;total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
- •Patients should participate in the study voluntarily and sign informed consent
排除标准
- •Patients who have been used anti-angiogenesis inhibitors,such as (such as sunitinib,bevacizumab,endostar et al.
- •Subjects with symptomatic brain metastases;
- •Patients whose primary lesion with active bleeding within 4 months
- •Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg
- •Patients with active or unable to control serious infections
- •Patients who are pregnant or breastfeeding.
研究组 & 干预措施
S1/Anlotinib
Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.
干预措施: S1/Anlotinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: each 21 days up to the toxicity or PD (up to 6 months)
measured by Response Evaluation Criteria in Solid Tumors version 1.1
progression-free survival (PFS)
时间窗: Duration of time from the start of treatment to the first documented disease progression according to RECIST 1.1 or death due to any cause, whichever occurs first, assessed up to 12 months
PFS will be estimated using standard Kaplan Meier survival analysis methods.
次要结局
- Overall survival (OS)(Duration of time from the start of treatment to date of death, assessed up to 2 years)
- Incidence of adverse events(Up to 2 years)
研究者
Haihua Yang
Head of Department of Radiation Oncology
Taizhou Hospital