Extensive stage-small cell lung cancer
Conditions
Interventions
Unimpeded:Anlotinib Hydrochloride
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, ES-SCLC patients with clear histological or cytological diagnosis; 2. There is at least one measurable objective lesion, which is evaluated with RECIST 1.1 standard; 3. The standard first-line chemotherapy plan of 4-6 cycles has been completed, and the efficacy evaluation is complete remission (CR), partial remission (PR) or stable condition (SD), and no other vascular targeted drug treatment has been received; 4. The evaluation of physical condition is based on Karnofsky activity rating scale, KPS score = 60 points; 5. It is estimated that the survival period of patients should be more than 3 months; 6. The hematopoietic system, heart, lung, liver, kidney and other important organs have good functions, that is, the following requirements shall be met one week before enrollment: Blood routine examination: without blood transfusion and blood products within 14 days, and without the use of G-CSF and other hematopoietic stimulating factors, White blood cell count (WBC) > 3.0 × 109/L, neutrophil count (NEUT #) > 1.5 × 109/L, platelet count (PLT) > 80 × 109/L, hemoglobin (HGB) > 80g/L; Liver function: alanine aminotransferase (ALT) < 50.0U/L, aspartate aminotransferase (AST) < 40.0U/L, total bilirubin (Tbil) = 16.50umol/L (AST/ALT = 5 times the upper limit of normal value is allowed in case of liver metastasis); Kidney: serum creatinine = 1.5 times the upper limit of normal value (the standard can be appropriately relaxed for patients with liver metastasis; serum creatinine (Cr) (enzyme method) < 106.0 umol/L or creatinine clearance rate = 50 ml/min (Cockcroft/Default formula). Heart: left ventricular ejection fraction = 50%; 7. No malabsorption or other gastrointestinal diseases affecting drug absorption; 8. Women of childbearing age must have a pregnancy test within 7 days before starting treatment and the result is negative; Effective contraception during the study period. Male of childbearing age: contraceptive measures shall be taken during surgical sterilization or treatment and within 3 months after the end of treatment; 9. All subjects in this study follow the principle of voluntariness. Before joining, patients voluntarily signed an informed consent form, with good compliance, and actively cooperated with doctors in clinical observation and follow-up.
Exclusion criteria
Exclusion criteria: 1. Allergies to anotinib hydrochloride; 2. According to the investigator's judgment, there is evidence of serious or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, cardiac, liver or kidney diseases); 3. Patients who have a history of hypertension and can not be reduced to the normal range (systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg) after treatment with antihypertensive drugs, have coronary heart disease of Grade II or above, arrhythmia or Grade III/IV cardiac insufficiency; 4. There is a high risk of gastrointestinal and respiratory bleeding, including active gastrointestinal ulcer lesions and fecal occult blood (2+); Recent history of hematemesis or melena; Recently, there are a large number of hemoptysis patients and other situations that researchers think may increase the risk of massive hemorrhage; 5. Patients with abnormal coagulation function, international normalized ratio (INR)>1.5, activated partial thromboplastin time (APTT)>1.5 ULN, and bleeding tendency; 6. Patients who have participated in clinical trials of other drugs in the past month; 7. Patients who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders; 8. Pregnant or lactating women; 9. According to the grading standard of common side effects of chemotherapy of the National Cancer Institute (NCICTC, Version 4.0), patients with chronic toxic reactions of more than 2 levels (excluding hair loss) have not recovered; 10. The researchers believe that the subjects may not be able to complete the study or may not be able to comply with the requirements of the study (due to management reasons or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective response rate;Quality of life;Safety; | — |
Countries
China
Contacts
Public ContactFanming Kong
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed