Non-small cell lung cancer
Conditions
Interventions
test group:CAPRI cell
Sponsors
the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. All subjects must be informed about this trial before beginning any inspections prescribed by this trial, and voluntarily sign a written informed consent (ICF) approved by the ethics committee; 2. Male or female, aged 18 to 60 years old (including 18 years old and 60 years old); 3. According to the 8th edition standard of TNM staging of the International Society for Lung Cancer Research. After clinical manifestations, auxiliary imaging, histology, and cytological examinations, diagnosed as primary stage ?A-?B NSCLC; 4. According to the clinical diagnosis and treatment guidelines for lung cancer of the Oncology Branch of the Chinese Medical Association. Those who are resectable, can accept comprehensive treatment based on surgery, and meet the target indications of CAPRI injection therapy; 5. No platinum-based chemotherapy contraindications, and agree to receive 4 cycles of platinum-containing adjuvant chemotherapy unanimously recommended by the Chinese Anti-Cancer Association and the Chinese Medical Association after radical resection, using a dual-drug regimen based on cisplatin, and its combined drugs Including vinorelbine, gemcitabine, docetaxel, paclitaxel, albumin-bound paclitaxel, pemetrexed (only for non-squamous cell carcinoma) and etoposide; for subjects who cannot tolerate cisplatin, A dual-drug regimen based on carboplatin can be used; 6. CTC, CTDNA or tumor tissue examinations did not find that EGFR was positive for sensitive mutations and/or ALK mutations; 7. ECOG physical strength score = 12 months, and can be followed up in accordance with the plan; 9. Blood system, liver, kidney and blood coagulation function are acceptable: white blood cell (WBC) >= 3.5 x 10^9/L, platelet (PLT) >= 80 x 10^9/L, absolute neutrophil count >= 1.5 x 10^9/L, hemoglobin >= 90g/L; total bilirubin= 60mL/min (using Cockcroft-Gault method); international standardized ratio (INR) <= 1.5; 10. Qualified subjects with fertility (male and female) must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence) during the trial and at least 1 year after the last infusion of chain activated immune cells (CAPRI) injection ; Female subjects of childbearing age must have a negative blood human chorionic gonadotropin (hCG) pregnancy test within 7 days before enrollment; male subjects cannot perform sperm donation from the first reinfusion to 1 year after the last reinfusion.
Exclusion criteria
Exclusion criteria: 1. During the trial period, plan to receive other anti-tumor treatments (unplanned chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, radiotherapy, experimental drugs with anti-tumor indications or Chinese medicine, etc.); 2. Cannot tolerate CT or MRI contrast agents and/or are allergic to contrast agents; 3. At the time of screening, the adverse reaction (ADR) of any previous treatment has not yet recovered to the Common Terminology Criteria for Adverse Events (CTCAE) 5.0 grade evaluation 160mmHg and/or diastolic blood pressure>100mmHg) or cardiovascular and cerebrovascular diseases of clinical significance (such as activity), such as cerebrovascular accidents (within 6 months before signing the informed consent) , Myocardial infarction (within 6 months before signing the informed consent), unstable angina, New York Heart Association (NYHA) grade II or above congestive heart failure, severe arrhythmia cannot be controlled by drugs or treated in trials Have potential impact 5. Combined with other serious organic diseases and mental illnesses; 6. Suffering from systemic active infections requiring treatment, including but not limited to active tuberculosis, known HIV-positive subjects, or clinically active subjects with hepatitis A, B, and C; 7. Suffering from autoimmune diseases: such as inflammatory bowel disease, systemic lupus erythematosus, vasculitis, infiltrating lung disease, and other autoimmune diseases judged by the investigator as unsuitable for this test (except subjects with vitiligo); 8. Systemic use of cortisol, hydroxyurea, or other immunomodulators (for example: alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.), including plans within 4 weeks before screening or during the trial use; 9. History of organ transplantation, allogeneic stem cell transplantation or kidney replacement therapy; 10. Diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver and kidney failure that cannot be effectively controlled; 11. Known alcohol and/or drug abusers; 12. People with allergies and multiple drug allergies, or those who are known to be allergic to any of the ingredients in the chain activated immune cell (CAPRI) injection; 13. Suffered from other malignant tumors in the past 5 years or at the same time (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix, except for those with no recurrence> 3 years after radical mastectomy); 14. Women who are pregnant or breastfeeding, or have a childbirth/pregnancy plan within 1 year after the last infusion; 15. The investigator judges that he has any complications or comorbidities that affect the evaluation of this trial; 16. The investigator judged that it was difficult to complete the visits, evaluations, or follow-ups specified in the trial protocol, or had poor compliance with the trial, or was not suitable for selection for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse time and serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Yi
the First Affiliated Hospital, Zhengzhou University
Outcome results
None listed