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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT02929693
Eligibility Criteria:
Inclusion Criteria:
* Pathologically or cytologically confirmed stage IIIa-IV pulmonary adenocarcinoma;
* With activating EGFR mutation (either exon19del or exon21L858R) and one month of gefitinib as first-line or second-line therapy without disease progression (PD);
* With TCM diagnostic pattern Qin-and-yin dificiency;
* Age ≥18 years old;
* Estimated life expectancy of at least 12 weeks;
* Without major organ dysfunction: hemoglobin ≥9 g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥100 \*109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable with liver metastasis).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;
Exclusion Criteria:
* with other malignant tumor except NSCLC 5 years previous to study entry;
* PD after onee month of gefitinib treatment
* Estimated life expectancy less than 12 weeks;
* Brain metastasis with relevant symptoms
* History of cardiovascular disease: Congestive Heart Failure \> grade II in NYHA.Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months;
* Pregnant or child breast feeding women;
* Mental or cognitive disorders;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02929693
Study Brief:
Protocol Section:
NCT02929693