Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT01924195
Eligibility Criteria:
Inclusion Criteria:
1. pathology diagnosed with advanced NSCL with measurable lesions;
2. Have failed for 2 lines of chemotherapy;
3. 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;
4. Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
5. main organs function is normal;
6. must be agreed to take contraceptive measures during the study and within 6 months after end.
Exclusion Criteria:
1. SCLC(including mixed with NSCLC);
2. the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
3. patients failed to use the anti-tumor angiogenesis therapy;
4. patients has many influence factors toward oral medications ;
5. Brain metastases patients accompanied by symptoms or symptom control for less than two months;
6. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)\>10mmol/L);urine protein≥++,etc.
7. patients failed to heal wounds or fractures for Long-term;
8. 4 weeks before enrollment, patients appeared NCI CTC AE grading \>1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade\> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
9. patients occurred venous thromboembolic events within 6 months;
10. patients has HIV-positive or organ transplantation;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01924195
Study Brief:
Protocol Section:
NCT01924195