Clinical trial · Interventional
Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)
Autologous Tcm Cells Immunotherapy in Patients With High-risk Recurrent Stage II Non-Small Cell Lung Cancer (NSCLC) After Postoperative Chemotherapy
NCT03432156CI-TRIAL-00036205unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Tcm cells immunotherapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- subjects who are treated with autologous Tcm cells immunotherapy
- interventionNames
- Biological: Autologous Tcm cells immunotherapy
- type
- NO_INTERVENTION
- label
- No intervention group
- description
- subjects who are treated without autologous Tcm cells immunotherapy
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- 12 weeks
- description
- This study will evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy according to progression-free survival (PFS) .
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.