Non-small cell carcinoma
Conditions
Interventions
Intervention group:DEB-BACE treatment (the drug loaded on the drug-loaded microsphere was carboplatin, with an AUC of carboplatin =5, one-third of which was used for the drug-loaded microsphere (Jiang
Sponsors
Zhoukou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent form; 2. Age > 18 years old, male or female; 3. ECOG score 0~2 points; 4. Expected survival = 12 weeks; 5. Patients with histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) and refusing standard treatment stage II.A-IIIC (as judged by the International Association for the Study of Lung Cancer (IASLC) Thoracic Tumor Staging Manual 9th Edition); 6. Patients who cannot tolerate radiotherapy ± chemotherapy (such as old age, poor PS score or comorbidities, etc.) or refuse radiotherapy±chemotherapy and surgery as assessed by the investigator; 7. CTA suggests that there is a bronchial artery involved in the blood supply of the tumor; 8. Patients have at least one measurable lesion (according to RECIST 1.1 criteria); 9. No EGFR or ROS sensitive mutations or ALK gene rearrangements/patients; 10. No previous systemic therapy for locally advanced NSCLC; 11. Normal function of major organs, that is, meeting the following criteria: (1) Routine blood examination standards must meet (no blood transfusion and blood products within 7 days, no correction by G-CSF and other hematopoietic stimulating factors): A. Hemoglobin (Hb) >= 90 g/L; B. Neutrophil count (ANC) >= 1.5 × 10^9/L; C. Platelet count (PLT) >= 100 ×10^9/L; (2) Biochemical examination must meet the following standards: A. Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); D. Routine urine test results show urine protein (UPRO) < 2+ or 24-hour urine protein quantitative < 1g; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = the low limit of normal (50%); (4) Coagulation function: International normalized ratio (INR) <=1.5×ULN and activated partial thromboplastin time <=1.5×ULN; 12. Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating patients; Men should agree to use contraception during the study and for 6 months after the end of the study period Patients who must use contraception;
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to treatment drugs; 2. Histologically or cytologically confirmed mixed NSCLC, neuroendocrine carcinoma and sarcomatoid carcinoma; 3. Patients with severe pulmonary fibrosis and pulmonary hypertension and those with reduced pulmonary circulation blood supply due to various reasons; 4. Those with a large amount of pleural effusion and pericardial effusion with poor control; 5. Allergic to iodine-containing contrast agents, unable to lie on their backs, unable to cooperate with puncture, intubation and contrast; 6. Those who are found to be unable to over-select intubation to completely avoid dangerous blood vessels such as spinal arteries; 7. Active autoimmune disease or immunodeficiency, or history of the following, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.) are not included. Exceptions are made for patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy and may be included in the study. People with type 1 diabetes who have blood sugar control after treatment with an insulin dosing regimen can participate in this study. 8. Those who have had arterial/venous thrombotic events within 6 months before the first dose, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis and pulmonary embolism; 9. Participated in another clinical study within 28 days before the first use of the test drug and used any of the test drugs; 10. Vaccinated or planned to be vaccinated with live attenuated vaccines within 4 weeks before the first dose; 11. Subjects who have had other malignant tumors in the past or at the same time within 5 years need active treatment (except for those who have been adequately treated, such as expected 5-year survival> 90% basal cell or squamous epithelial cell skin cancer, cervical carcinoma in situ, and breast cancer in situ); 12. Significant clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure New York Heart Association (NYHA) grade >= 2; Ventricular arrhythmias requiring medical treatment (including QTc interval male >= 450 ms, female >=470 ms); Left ventricular ejection fraction (LVEF) =CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia, unexplained fever >38.5°C before the first dose (according to the investigator's judgment, fever caused by tumor causes can be enrolled); 14. Subjects who require systematic treatment with corticosteroids (> 10mg/day of prednisone or equivalent dose of similar hormones) or other immunosuppressive agents within 14 days before the first administration of the trial drug. Exceptions include: 1) Intranasal, inhaled, topical steroid therapy or local injection, steroid drugs (such as intra-articular injections); 2) steroids as prophylactic administration for hypersensitivity reactions (such as pre-treatment for CT scans); 3) prophylactic systemic steroid administration as part of chemoradiotherapy treatment for locally advanced NSCLC; 15. History of immunodeficiency, including positive HIV test or other ac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;Disease Control Rate,?DCR;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactLiu Yong
Zhoukou Central Hospital
Outcome results
None listed