lung cancer
Conditions
Interventions
treatment group 1:concurrent chemoradiotherapy combined with anlotinb 8mg
treatment group 2:concurrent chemoradiotherapy combined with anlotinb 10mg
treatment group 3:concurrent chemoradiotherapy combined with anlotinb 12mg
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Patients pathologically diagnosed as locally advanced (III) unresectable non-small cell lung cancer; 3. ECOG (Eastern Cooperative Oncology Group) 0~1; 4. Patients who have failed after at least two systemic chemotherapy (EGFR mutations and ALK/ROS1 positive patients also need to undergo progression after the corresponding targeted therapy); 5. No surgery history; 6. The damage from other treatments had been recovered, with the interval between nitrocellulose or mitomycin for up to six weeks. To receive other cytotoxic drugs, bevacizumab (Avastin) = 4 weeks; EGFR TKI class of targeted drugs = 2 weeks; 7. The main organ function is normal, which meets the following criteria: (1) the standard of blood test should be met (14 days without blood transfusion and blood products, no G-CSF and other hematopoietic stimulation factor correction): Hb=90g/L;ANC=1.5×10^9/L;PLT=80×10^9/L; (2) biochemical inspection shall meet the following criteria: TBIL 50 ml/min (the Cockcroft Gault formula); 8. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) =50% lower limit of normal (LLN); 9. Participants voluntarily joined the study, signed informed consent, and had good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer); 2. Patients with empty lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis (>20 mL/day); 3. Imaging shows that the tumor has been violated around important vascular or the researchers determine the tumor is likely to invade important blood vessels caused by fatal bleeding during the follow-up; 4. People with high blood pressure and can not be reduced to a normal range (systolic > 140 mmHg, diastolic > 90 mmHg). A person with a history of unstable angina; In the first 3 months of screening, the new diagnosis was a cardiac myocardial infarction in the first six months. Cardiac arrhythmias (including QTcF greater than 470 ms) require long-term use of arrhythmias and the New York heart association (New York heart association); 5. Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 6. The coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency is used anticoagulants or vitamin K antagonists such as warfarin and heparin or its analogues treatment; 7. urine routine test protein=++, and confirmed 24 hours urine protein>1.0 g; 8. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc. 9. Patients with venous thrombotic occurred within 12 months before allocation, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 10. Patients participated in other anti-tumor drug clinical trials within 4 weeks; 11. The researchers judged other conditions that could affect clinical research and the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;MTD; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;1-year survival rate;3-year survival rate;drug safety;disease control rate;Tumor markers; | — |
Countries
China
Contacts
Public ContactHongbing Ma
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed