S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer

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.

Inclusion criteria

• 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

Exclusion criteria

• 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.