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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02714608
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis)
2. The patients who can not be treated by surgical resection, conventional radiotherapy and chemotherapy or molecular targeted drugs treatment failure, not willing to accept, or intolerance to radiotherapy and chemotherapy or molecular targeted therapy.
3. The TCM Syndrome diagnosis of Qi-Deficiency.
4. Aged 18-75 years, both male and female.
5. ECOG performance status 0-2.
6. Expected to survive more than 3 months.
7. Joined in the test voluntarily and signed the Informed consent by GCP regulation.
Exclusion Criteria:
1. Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr).
2. Patients with significant cachexia.
3. Untreated symptomatic brain metastases.
4 .Allergic constitution, or for a variety of drug allergy.
5 .Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath.
6\. Participated in other clinical trial within 3 months.
7\. Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.
8\. Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.
9\. Not fit for the clinical trial judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02714608
Study Brief:
Protocol Section:
NCT02714608