Small cell lung cancer
Conditions
Interventions
Case series:Anlotinib plus EC as first line treatment
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study, sign informed consent, and have good compliance; 2. Treatment-na?ve patients with extensive stage small cell lung cancer diagnosed by pathology; 3. At least one measurable lesion was confirmed according to RECIST 1.1; 4. Aged 18 to 75 years; 5. ECOG PS score 0~1; 6. The expected survival time is more than 3 months; 7. Within 7 days before treatment, the function of the major organs meets the following criteria: Standard of blood routine examination (without blood transfusion within 14 days): (1) Hemoglobin (HB) >=90g/L; (2) Absolute value of neutrophils (ANC) >=1.5x10^9/L; (3) Platelet (PLT) >=80x10^9/L. Biochemical examination shall meet the following standards: (1) Total bilirubin (TBIL) =60 ml/min; Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= LNL (50%). 8. Women of childbearing age should agree to use contraceptives (such as iUDs, contraceptives or condoms) during the study period and for a period of six months after the study;Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Men should agree to use contraception during the study period and for six months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously used chemotherapy or anlotinib; 2. Patients who have previously used other targeted drugs (such as bevacizumab etc.) and immune-targeted drugs; 3. Patients with bleeding tendency (e.g., active gastrointestinal ulcers) or those treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Low-dose warfarin (=3) to the active ingredients and/or any excipients of the drug in question are known; 5. Had or currently had other malignant tumors within 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1(tumor infiltrating basement membrane)]; 6. Had received chemotherapy, radiotherapy or other experimental anticancer therapies within 4 weeks before the first dose of experimental drug treatment; Those who have received local radiotherapy in the past can be enrolled if they meet the following conditions: more than 4 weeks from the end of radiotherapy to the start of the treatment (more than 2 weeks for brain radiotherapy); Moreover, the target lesion selected in this study is not within the radiotherapy area. Or the target lesion is located in the radiotherapy area, but the progress has been confirmed. 7. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 8. Subjects with cancerous meningitis; 9. Subjects with known central nervous system metastasis and/or spinal cord compression; Unless asymptomatic, or treated and stable, no imaging evidence of new brain metastases or enlarged brain metastases was found at least 2 weeks after treatment of the brain metastases, and steroid or anticonvulsant therapy was discontinued for at least 14 days prior to study treatment initiation; 10. Uncontrolled pleural effusion, pericardial effusion and peritoneal effusion requiring repeated drainage; 11. Patients with any severe and/or uncontrolled disease, including: (1) Patients whose blood pressure control is not ideal (systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg); (2) Having grade I or above myocardial ischemia or infarction, arrhythmia (including QTc >=450ms(male) or QTc >=470ms(female) and grade >=2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled severe infection (>=CTC AE level 2 infection); (4) Antiviral treatment for cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (7) poor control of diabetes mellitus (FBG) > 10mmol/L; (8) urine routine indicated urinary protein >=++, and confirmed 24-hour quantitative urinary protein >1.0g; (9) patients with epileptic seizures requiring treatment; 12. Received major surgical treatment, open biopsy or significant traumatic injury within 28 days before grouping; 13. Patients whose tumors have invaded around important blood vessels according to imaging findings or whose tumors are likely to invade import
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR; | — |
Countries
China
Contacts
Public ContactBaohui Han
Shanghai Chest Hospital
Outcome results
None listed