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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT03432156
Eligibility Criteria:
Inclusion Criteria:
1. Be willing and able to provide written informed consent for the study.
2. Subjects with pathologically confirmed stage II NSCLC.
3. Subjects with stage II NSCLC had treatment with surgical resection and 4 cycles of postoperative adjuvant chemotherapy before the study.
4. Karnofsky (KPS) ≥ 60.
5. One or more Serum tumor markers such as carcinoembryonic antigen (CEA), CA125, cytokeratin-19 fragment (CYFRA21-1), neuron-specific enolase (NSE), pro-grp and angiopoietin-2 (Ang-2) are double higher than normal level or durative elevator on three consecutive tests.
6. Adequate hematologic and end-organ function.
7. Subjects who could receive treatment with at least 3 cycles of autologous Tcm cells immunotherapy.
8. Subjects must be received auxiliary examination and record these results in detail before and after immunotherapy.
9. Subjects must meet the indications for autologous Tcm cells immunotherapy.
Exclusion Criteria:
1. Subjects with lung nodules, lymph nodes, brain, liver, bone or adrenal metastasis before the study.
2. Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.
3. Subjects with severe abnormality of coagulation.
4. History or any evidence of hemorrhage.
5. Subjects with severe infection or high fever.
6. Subjects with severe autoimmune diseases.
7. Subjects with persistent or intractable epilepsy.
8. Subjects with merging other malignant neoplasms.
9. Subjects with mental disorder.
10. Subjects with heart, liver or kidney diseases.
11. Major surgeries except for surgical resection of NSCLC were performed in 4 weeks before the study.
12. Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
13. Concurrent treatment or treatment on another study in 4 weeks before the study.
14. Pregnancy or breast-feeding.
15. There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial.
16. Any condition that would interfere with or endanger the safety and compliance of subjects.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03432156
Study Brief:
Protocol Section:
NCT03432156