small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Diagnosed with extensive stage SCLC through pathology, with measurable nidus; 3. Disease progression after second-line and above chemotherapy; 4. ECOG PS 0-2; 5. The subject has recovered from the damage caused by other treatments. For example, interval=6 weeks after nitroso or mitomycin; =4 weeks after other cytotoxic drugs or bevacizumab; =2 weeks after target EGFR TKI medicines; 6. Adequate organ function, defined as: Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^3/microliters (µL), hemoglobin greater than or equal to 9.0 grams/deciliter (g/dL), and platelets greater than or equal to 800 x 10^3/µL; Total bilirubin less than or equal to 1.5 xUpper Limit of Normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation is due to liver metastases,Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 60 milliliters per minute (ml/min) (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection), LVEF=50%; 7. No contraindications of radiotherapy or amlotinib; 8. Signed and dated informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with NSCLC through pathology; 2. Small cell lung cancer along with hemoptysis (>20ml/day); 3. Patients with significant bleeding risk; 4. Uncontrolled arterial hypertension greater than or equal to 150/90mmHg despite standard medical management; Having a history of unstable angina pectoris; Clinically relevant congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia (including QTC=480ms) myocardial ischemia or myocardial infarct; 5. Patients with abnormal coagulation function (INR>1.5 or PT>ULN+4 sec or APTT >1.5 ULN), or bleeding tendency, or being take anticoagulants such as warfarin and heparin; 6. Get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents, deevenous thrombosis, and pulmonary embolism; 7. Urinary protein quantitative value=2+and quantitative protein is >1.0g in a 24 hour urine sample 8. With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus); 9. Have participated in other clinical trials of anti-tumor medicine within 4 weeks; 10. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Countries
China
Contacts
Third Clinical School of Xinjiang Medical University (Affiliated Tumor Hospital)