Non-Small Cell Lung Cancer
Conditions
Interventions
Case series:Treatment with Cindilizumab
Sponsors
Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Three armour hospital image diagnosis of early lung cancer and multidisciplinary consultation diagnosed with multiple pulmonary high-risk GGN, and partially after surgical resection, at least a solid residue has a lung nodules (mediastinal window visible solid component) size is 8 mm or higher, and the internal composition of solid lesions > 5 mm in diameter (high risk), and surgery, patients with risk factors or result in patients not suitable for surgery, but patients with radiation SBRT indications; 2. Adults older than 18 years and no more than 70 years; 3. Pathological diagnosis was microinvasion adenocarcinoma at least; 4. ECOG score 0-1; 5. The postoperative gene test driver gene positive population is allowed to be enrolled, but the proportion is limited (e.g., 30%); 6. The main organs have good functions and meet the following requirements (excluding any blood components and cell growth factors used within 14 days before the first drug use): Blood routine examination:Hemoglobin 90 g/L (no transfusion within 14 days); Neutrophil count > 1.5*10^9/L; Platelet count 75*10^9/L; Biochemical examination:Total bilirubin 1.5 ULN (upper limit of normal value); ALT or AST less than 2.5 ULN; ALT or AST < 5 ULN in the case of liver metastasis; AKP 2.5 x ULN or less; Endogenous creatinine clearance was more than 60 ml/min (Cockcroft-Gault formula).Serum albumin 30g/dL; No life-threatening electrolyte abnormalities Thyroid stimulating hormone (TSH) ULN(if abnormal, FT3 and FT4 levels should be examined at the same time; if normal FT3 and FT4 levels, they can be enrolled); If the results of ECG examination are abnormal, it shall be determined by researchers or cardiologists that there is no obvious clinical significance (it has no obvious influence on receiving anti-pd-l1 treatment). Cardiac doppler ultrasonography evaluation: left ventricular ejection fraction (LVEF) 50%; 7. After evaluation, sufficient tissue samples after surgery can be used for biomarker detection and analysis; 8. The expected survival time is 24 months; 9. Contraceptive requirements: the serum pregnancy test results of women of childbearing age within 72 hours before the first use of the drug were negative. Subjects of reproductive age and male subjects with a partner of reproductive age will use effective contraception during the study period and within 180 days after the last administration of the study drug; 10. With good compliance, the family members agreed to cooperate with the survival follow-up; 11. All patients should sign consent.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or has a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis); Subjects with vitiligo or who have had complete remission from childhood asthma without any intervention in adulthood may be included; Subjects with asthma requiring medical intervention with bronchodilators; 2. The subject is using immunosuppressant, or systemic, or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose of >7.5mg/d prednisone or other therapeutic hormone), and is still using within 2 weeks before enrollment; 3. Severe allergic reactions to other monoclonal antibodies; 4. Patients with a variety of factors (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.) affecting oral drugs; 5. Patients with a history of unstable angina pectoris; Patients newly diagnosed with angina within 3 months before screening or myocardial infarction within 6 months before screening; 6. Arrhythmia (including QTcF: male 450 ms, female 470 ms) requires long-term use of anti-arrhythmia drugs and New York heart association grade II cardiac dysfunction; 7. Urine routine test indicated that urine protein was ++, and confirmed the 24-hour urine protein quantitative > 1.0g; 8. Long-term unhealed wounds or incomplete fractures; 9. Patients with abnormal coagulation function and bleeding tendency (the INR must be within the normal range in the absence of anticoagulant 14 days before randomization); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; The use of low-dose warfarin (1 mg oral, once daily) or low-dose aspirin (no more than 100 mg daily) for preventive purposes is permitted on the premise that the international standardized ratio of prothrombin time (INR) is no more than 1.5; Known genetic or acquired bleeding and thrombotic tendencies (e.g. haemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 10. Screening for events of hyperactive/venous thrombosis within the first 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except for venous thrombosis caused by venous catheterization in the early stage of chemotherapy, which has been determined to have been cured by the researcher) and pulmonary embolism; 11. Thyroid function has been abnormal in the past, and thyroid function cannot be maintained within the normal range even under the condition of drug treatment; 12. Subjects had active infection occurred prior to or during the screening, for the first time to give medicine unexplained fever > 38.5 degree C; 13. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severe impairment of lung function; 14. Patients with a history of psychotropic substance abuse and cannot quit or have a mental disorder; 15. Patients with a history of immune deficiency, or has other acquired, congenital immunodeficiency disease (subjects congenital or acquired immune function defects (such as H ? infection), or active hepatitis: hepatitis b reference: HBsAg positive and HBVDNA viral load of 200 iu/mL or acuity or 103 copies/mL). Hepatitis c reference: HCV virus titer or RNA detection value exceeds the upper limit of nor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Drug safety;DOR; | — |
Countries
China
Contacts
Public ContactLin Xu
Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University
Outcome results
None listed