Lung cancer
Conditions
Interventions
Experimental Group:Adebrelimab combined with anlotinib and chemotherapy
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up 2. Age >=18 years and = 10 mm Major organ function is normal and should meet the following criteria: 13. Pulmonary ventilation function test, FEV1>=1.5L, or expected FEV1>=800ml after lobectomy/pneumonectomy; 14. Routine blood test criteria (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): a) Hemoglobin (HB) > = 90 g/L b) Absolute neutrophil value (ANC) >=1.5×10^9/L c) Platelets (PLT) >=80×10^9/L; 15. Biochemical examination shall meet the following indicators: a) Total bilirubin (TBIL) = 60 ml/min. 16. The international normalized ratio (INR) of prothrombin time in patients who have not received anticoagulation therapy is <=1.5, and the partial thromboplastin time (APTT) is <=1.5 times the upper limit of normal. Patients receiving full or parenteral anticoagulant therapy may enter the clinical trial as long as the dose of the anticoagulant is stable for at least 2 weeks prior to entering the clinical study and the results of the coagulation assay are within the limits of local treatment; 17. Women of childbearing age (15~49 years old) must have a urine pregnancy test within 7 days before starting treatment and the result is negative.
Exclusion criteria
Exclusion criteria: 1. Large cell carcinoma and mixed cell lung cancer; 2. Patients whose imaging shows that the tumor has invaded the perivascular area of important blood vessels, or the investigator judges that the tumor is very likely to invade important blood vessels during the follow-up study and cause fatal hemorrhage; or the presence of significant pulmonary cavitary or necrotic tumors; 3. Have undergone any systemic anti-cancer therapy for NSCLC, including cytotoxic drug therapy, immunodrug therapy, and trial therapy; 4. Local radiotherapy for NSCLC; 5. Patients with other cancers other than NSCLC within five years prior to the start of treatment in this study. excludes carcinoma in situ of the cervix, cured basal 7-cell carcinoma, bladder epithelial tumors [including Ta and TIS]; 6. Patients who have previously used anlotinib and other anti-angiogenic drugs; 7. Patients who have previously used PD-1, or other anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, and any other antibody or drug therapy against T-cell co-stimulation or checkpoint pathways, such as ICOS or agonists (such as CD40, CD137, GITR, OX40, etc.); 8. Hypersensitivity to anlotinib or any component of PD-L1 or chemotherapy drugs; 9. Patients with multiple factors that affect oral medication (such as: inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 10. Patients with any severe and/or uncontrolled disease, including: Patients with unsatisfactory blood pressure control (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); Patients with grade I or greater myocardial ischemia or myocardial infarction, arrhythmias (including QTc>=480ms) and >=grade 2 congestive heart failure (New York Heart Association (NYHA) classification); Abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), with bleeding tendency or being treated with thrombolysis or anticoagulation; Note: Under the premise of the international normalized ratio (INR) of prothrombin time 10 mmol/L); Those whose urine routine showed urine protein >=++, and confirmed 24-hour urine protein quantification >1.0g; Patients who have seizures and require treatment; long-term unhealed wounds or fractures, etc.; 11. Prior interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy, or any active interstitial lung disease with clinical evidence; 12. Patients with arterior/venous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 13. Current presence of peripheral neuropathy of >=CTCAE 2nd degree, except as a result of trauma; 14. Patients requiring total right lung resection; Subjects who have had major surgery or have severe trauma have had the effects of surgery or trauma resolved for less than 14 days prior to enro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response;Objective response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactMeng Wang
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed