non-small cell lung cancer, NSCLC
Conditions
Interventions
ct-DNA negative experimental group:Neoadjuvant immunotherapy with toripril combined with neoadjuvant chemotherapy (squamous cell carcinoma: paclitaxel or docetaxel + platinum
Non-squamous cell carcinoma: culture Metrexed + platinum) were administered every 3 weeks for 3 cycles
ct-DNA negative control group:neoadjuvant therapyNeoadjuvant chemotherapy (squamous cell carcinoma: paclitaxel or docetaxel + platinum
Non-squamous cell carcinoma: pemetrexed + platinum), every 3 weeks for 3 cycles
ct-DNA positive experimental group:Neoadjuvant immunotherapy with toripril combined with neoadjuvant chemotherapy (squamous cell carcinoma: paclitaxel or docetaxel + platinum
ct-DNA positive control group:Neoadjuvant immunotherapy with toripril combined with neoadjuvant chemotherapy (squamous cell carcinoma: paclitaxel or docetaxel + platinum
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: =18 years old, male or female; 2. Patients with pathologically confirmed stage II NSCLC and negative driver genes(ALK;EGFR;ROS-1); 3. Pulmonary function indicators meet the surgical standards; 4. ECOG PS: 0-1 5. No previous systemic anti-tumor therapy; 6. Baseline blood routine and biochemical parameters met the following criteria: -Hemoglobin =80g/L, absolute neutrophil count (ANC) =1.5×109/L, platelet =90×109/L, -ALT, AST=2.5 times the upper limit of normal, =5 times the upper limit of normal (for HCC), -total serum bilirubin =1.5 times the upper limit of normal, serum creatinine =1.5 times the upper limit of normal; Serum albumin =30g/L, proteinuria < 2 + detected by urine dipstick; 7. Expected survival time =3 months; 8. Women of childbearing age had to have a negative serum test within 28 days before starting study treatment. If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test; 9. Women must not breastfeed; 10. The subjects voluntarily participated in this study, signed the informed consent form, with good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. The patient had received neoadjuvant therapy, including chemoradiotherapy, targeted therapy, and immunotherapy Treatment; 2. Severe allergic reactions to other monoclonal antibodies; 3. To pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin, or prophylaxis thereof Had a history of severe allergy. 4. Have a history of immunodeficiency or other acquired or congenital immunodeficiency diseases Disease or a history of organ transplantation; 5. Patients with hypertension that cannot be reduced to the normal range with antihypertensive medication (contraction Blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) and grade I or above coronary heart disease Grade I arrhythmia (including QTc interval prolongation > 450 ms in male and female) > 470 ms) and grade I cardiac insufficiency; Patients with positive urine protein; 6. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN) with bleeding inclination Toward; 7. Patients with central nervous system metastases; 8. Pregnant or lactating women; 9. Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders Of; 10. Patients who participated in clinical trials of other drugs within 4 weeks; 11. According to the investigator's judgment, there is a serious harm to patient safety or impact on patient well-being Patients with concomitant diseases into the study; 12. Persons deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR (pathologic complete response); | — |
Secondary
| Measure | Time frame |
|---|---|
| ctDNA;EFS (Event-free survival);Major pathological response rate;R0 resection rate;the rate of ctdna clearance ;OS (overall survival);vital signs;laboratory examination; | — |
Countries
China
Contacts
Public ContactBin Hu
Sichuan Cancer Hospital & Institute
Outcome results
None listed