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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT03931720
Eligibility Criteria:
Inclusion Criteria:
1. Age 18\~75 years old, male or female
2. Life expectancy ≥ 6 months
3. ECOG score: 0-3
4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
5. Advanced solid tumor was diagnosed by pathological or clinical physicians
6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥70 x 10\*9/L, hemoglobin≥80g/L, lymphocyte count≥15%, total bilirubin≤100 mol/L, ALT and AST less than five times of the normal level, serum creatinine less than 1.5 times of the normal level
7. Signed informed consent
8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion
Exclusion Criteria:
1. Expected overall survival \< 6 months
2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months
3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%
4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03931720
Study Brief:
Protocol Section:
NCT03931720