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:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT02652234
Eligibility Criteria:
Inclusion Criteria:
* Histological/cytological confirmed unresectable stage ⅢB～Ⅳ non-squamous NSCLC
* ECOG performance status 0-1
* Life expectancy≥3 months
* Adequate hematologic function: WBC≥3.0×109/L ,ANC≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L;
* Adequate hepatic and renal function: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN, creatinine≤1×ULN, creatinine clearance≥50ml/min;
* Normal coagulation function (PT, APTT, TT, Fbg) ;
* Patients signed informed consent form;
* Willingness and capability to comply with protocol requirement and well communicate with investigators.
Exclusion Criteria:
* With uncontrolled ascites or pleural effusion;
* Patients receiving a chest or abdominal surgery within 28 days before enrollment; or with not fully healed surgical incision; or expected to receive surgery during the study;
* History of ischemic or TIA within 6 months before enrollment;
* Uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy;
* Arrhythmias need to be treated; history of coronary artery disease (including angina pectoris and myocardial infarction) or ischemic myocardium; congestive heart-failure NYHA class ≥ II；
* Serious active infections;
* History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
* Symptomatic brain or meningeal metastasis;
* Epileptic seizure need to be treated;
* HCV, HBV or HIV positive;
* History of other malignant tumors within 5 years (except curable cervix carcinoma in situ or skin basal cell carcinoma);
* Known allergies to any excipient in the study drug;
* Any conditions that may interfere with the patient's participation in the study or have an impact on the assessment of the results of the study;
* Any conditions that may endanger patient safety or interfere with the patient's compliance;
* Pregnant and lactating women;
* The investigators consider the patients unsuitable for this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02652234
Study Brief:
Protocol Section:
NCT02652234