Non-small Cell Lung Cancer
Conditions
Interventions
Experience group:Docetaxel 60-75mg/m2, first day, 21 days a week Anlotinib 12 mg/tablet, one tablet at a time, once a day, before meals (take at the same time every day as possible). Continuous oral a
Sponsors
Nanyang Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Aged 18 years and above; 2 Recurrent or metastatic advanced non-small cell lung cancer (NSCLC) diagnosed by pathology and imaging has measurable lesions (according to RECIST 1.1 criteria); 3 Recurrent or metastatic advanced NSCLC patients who have received systemic first-line chemotherapy in the past; 4 ECOG physical condition score: 0-1; 5 Predicted survival period (> 3 months); and 6 main organ function are good, no severe hypertension, diabetes and heart disease. That is to say, within the first 14 days of randomization, the relevant examination indicators meet the following requirements: (1) blood routine examination: i. hemoglobin (> 90 g/L) (no blood transfusion within 14 days); ii. neutrophil count > 1.5 *10^9/L; iii platelet count (> 100 *10^9/L); (2) biochemical examination: i. total bilirubin (< 1.5 *ULN) (upper limit of normal value); ii. ALT or AST (< 2.5 *ULN); if there is any. For liver metastasis, ALT or AST were less than 5 * ULN; iii. Creatinine clearance rate was more than 60 ml/min (Cockcroft-Gault formula); (3) Doppler echocardiography evaluation: left ventricular ejection fraction (LVEF) was more than 50%; (4) fasting blood glucose was less than 7.2 mmol/L, non-fasting blood glucose was less than 10 mmol/L, and glycosylated hemoglobin was less than 7%. 7 Sign informed consent; 8 Good compliance, family members agree to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1 Non-small cell lung cancer (NSCLC) patients who have used antiangiogenic drugs such as Anlotinib hydrochloride and docetaxel in the past; 2 patients with central, empty squamous cell lung cancer or non-small cell lung cancer accompanied by hemoptysis (>50ml/d), small cell lung cancer (including small cell and non-small cell lung cancer mixed); and 3 imaging showed that the tumor lesion was less than 5mm away from the large vessel, or had severe invasion. 4 Patients with active brain metastasis, cancerous meningitis, spinal cord compression with symptoms or symptom control time less than 2 months, or patients with brain or pia mater disease and brain metastasis detected by CT or MRI at screening time; 5 pregnant or lactating women, and patients with fertility are reluctant to do so. 6 uncontrollable hypertension (systolic or diastolic blood pressure (> 140 mmHg or 90 mmHg), despite the best drug treatment; 7 patients with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including male (> 450 ms) and female (> 470 ms) during the QTc interval; 8 According to NYHA criteria, patients with grade III-IV cardiac insufficiency; 9 Coagulation dysfunction (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulation therapy; 10 Treatment with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs. Note: On the premise that the International Standardized Ratio of Prothrombin Time (INR) is less than 1.5, low doses of heparin (0.6-12,000 U per day for adults) or aspirin (less than 100 mg per day) are allowed for preventive purposes; 11 Significant clinical bleeding symptoms or definite bleeding tendency occur within the first three months of screening, such as digestive tract effusion. Blood, hemorrhagic gastric ulcer, baseline fecal occult blood + or above, or with vasculitis; 12 Arteriovenous thrombosis events occurring within 12 months before screening, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 13 Known hereditary or acquired hemorrhage and thrombotic tendency (such as hemophilia, coagulation, etc.) Dysfunction, thrombocytopenia, hypersplenism, etc.. 14 Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening. 15 Major surgical operations or severe traumatic injuries, fractures or ulcers occurred within 4 weeks before screening. Oral drug absorption was significantly affected by factors such as inability to swallow, chronic diarrhea and intestinal obstruction. 16 Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months; 17 Urinary routine indicated that urinary protein (++) or confirmed 24-hour urinary protein (> 1.0g); 18 Those who had a history of psychotropic drug abuse and could not be cured or had mental disorders; 19 Those who participated in clinical trials of other antineoplastic drugs within the first 4 weeks of screening; 20 Those who had previously or concurrently suffered from other untreated malignant tumors, The cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Disease control rate;Overall Survival;Quality of life; | — |
Countries
China
Contacts
Public ContactRen Zhonghai
Nanyang Central Hospital
Outcome results
None listed