Advanced non-small cell lung cancer
Conditions
Interventions
single arm:combination of Anlotinib and conformal intensity modulated radiotherapy
Sponsors
The 924th Hospital of PLA Joint Logistics Support Force
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, ECOG PS score 0-1 2. Pathologically confirmed advanced (stage IIIB/IV) non-small cell lung cancer with measurable lesions 3. Life expectancy is not less than 12 weeks 4. At least one measurable lesion (according to the requirement of mRECIST, the length of spiral CT scan of the measurable lesion is more than 10 mm or the short diameter of enlarged lymph nodes is more than 15 mm). 5. The function of the main organs is normal, which meets the following criteria: 1) The standard of blood routine examination should be in conformity with: A) ANC (>= 1.0 *109/L) B) PLT (>= 75 *109/L); C) Hb >= 90g/L 2) The biochemical test must meet the following criteria; A) ALB (>= 29 g/L); B) ALT and AST = 5Oml/min (Cockcroft-Gault formula). 6. Women of childbearing age must be willing to use appropriate methods of contraception during the trial and eight weeks after the last trial. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and eight weeks after the last administration of the drug. 7. Subjects volunteered to join the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer mixed with non-small cell lung cancer; 2. Central, cavernous squamous cell lung cancer or non-small cell lung cancer with hemoptysis (>50 mL/day); 3. Patients whose tumors have invaded important blood vessels or who have been judged by researchers to be at risk of massive hemorrhage during subsequent studies; 4. Patients with any physical signs or history of bleeding or undergoing thrombolytic therapy; 5. Even with antihypertensive therapy, hypertension was uncontrolled according to CTCAE 4.0 before the start of the trial. CTCAE defines uncontrolled hypertension as > CTCAE2 hypertension; clinical defines uncontrolled hypertension as persistent hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) even after receiving standard medication. 6. Patients with the following cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval of men (>= 450ms) and women (>= 470ms); according to NYHA criteria, grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) =(++) or confirmed 24-hour urinary protein (>= 1.0g); 18. Serous effusion (including pleural effusion, ascites and pericardial effusion) which has clinical symptoms and needs symptomatic treatment; Note: Asymptomatic serous effusion can be admitted into the group. Symptomatic serous effusion can be treated with positive symptomatic treatment (can not be treated with anticancer drugs). The patients who can be admitted into the group can be judged by the researchers and allowed to be admitted into the group. 19. Active infections require antimicrobial treatment (e.g. antimicrobial and antiviral drugs, excluding chronic hepatitis B and antifungal drugs). 20. Those who have a history of psychotropic drug abuse and are unable to give up or have mental disorders; 21. Those who received potent CYP3A4 inhibitors within 7 days before randomization or those who received potent CYP3A4 inducers within 12 days before partic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;AFP; | — |
Countries
China
Contacts
Public ContactXie Yueyun
The 924th Hospital of PLA Joint Logistics Support Force
Outcome results
None listed