non-small cell lung cancer
Conditions
Interventions
case series:anlotinib combined with chemothrapy
Sponsors
Wuxi People's Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments; 2. Aged 18 to 75 years old on the day of signing the ICF; 3. Non-small cell lung cancer confirmed by pathology with measurable lesions(Spiral CT scan >= 10mm, defined per RECIST v1.1); 4. Patients with advanced non-small cell lung cancer who have received at least one chemotherapy regimens; 5. Treated patients with asymptomatic brain metastases; 6. ECOG performance status0-2; 7. Life expectancy >= 3 months; 8. Patients must have adequate organ function as indicated by the following laboratory values: (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelets >= 80 x 10^9/L, hemoglobin >= 90 g/L. Note: Patients must not have required a blood transfusion or growth factor support = 60 ml / min; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= normal low limit (50%). 9. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study(such as intrauterine devices, birth control pills or condoms) , and have a negative urine or serum pregnancy test <= 7 days of randomization. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Patients who had previously used Anlotinib Hydrochloride Capsules; 2. According to the investigator's judgment, there are patients with severe disease that are harmful to the safety of the patient or affect the patient's completion of the study; 3. Patients who have previously used other targeted drugs (such as sunitinib, bevacizumab, Endostar, etc) and immune-targeted drugs; 4. Have appeared or currently have other malignant tumors within 5 years, except for cured cervical carcinoma, non-melanoma skin cancer and superficial bladder tumor[Ta (non-invasive tumor), Tis (in situ carcinoma) and T1 (tumor infiltrating basement membrane)]; 5. Anti-cancer therapy for chemotherapy, radiotherapy or other tests within 4 weeks prior to the first dose of test drug treatment(Have received local radiotherapy in the past, can be enrolled if you meet the following conditions: end of radiotherapy is more than 4 weeks from the start of study treatment(brain radiotherapy for more than 2 weeks); and the target lesion selected in this study is not in the radiotherapy area; or the target lesion is located in the radiotherapy area, but has been confirmed progress); 6. Have factors that affects oral medication(such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 7. Subjects with known central nervous system metastasis and/or spinal cord compression; unless symptomatic, or treated and stable, no imaging evidence of new brain metastases or enlarged brain metastases found at least 2 weeks after brain metastases,and stop steroid or anticonvulsant medication for at least 14 days before the start of study treatment 8. Uncontrolled pleural effusion, pericardial effusion, and peritoneal effusion requiring repeated drainage; 9. Unresolved effects of prior therapy> CTCAE Grade 1 at the time of randomization, except for alopecia; 10. Patients with any severe and/or uncontrolled disease,including: a) Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >=100 mmHg); b) Have grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc >= 450ms (male), QTc >= 470ms (female)) and >= grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) Active or uncontrolled serious infection (>= CTC AE grade 2 infection); d) Coagulation dysfunction (INR > 1.5 or PT > normal upper limit 4s or APTT > 1.5 times increase), have bleeding tendency or coagulopathy or anticoagulant therapy; e) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy f) Renal failure requires hemodialysis or peritoneal dialysis; g) A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; h) Poor diabetes control (FBG>10mmol/L); i) Urinary routine suggests urinary protein >= ++, and confirmed 24-hour urine protein quantitation > 1.0 g j) Patients with seizures and need treatment. 11. Major surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to grouping; 12. Imaging studies have shown that the tumor has invaded the vital blood vessels or that the patient is likely to invade the important blood vessels and cause fatal bleeding during the follow-up study; 13. Regardless of severity, patients with any signs or history of hemorrhage; patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;disease control rate;overall survival; | — |
Countries
China
Contacts
Public ContactZhiqiang Hang
Wuxi People's Hospital
Outcome results
None listed