NSCLC
Conditions
Interventions
experimental group:Alotinib combined with PD-1
Sponsors
The First Affiliated Hospital of Xinxiang Medical College
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects are >= 65 years old when they sign the informed consent form, both male and female; 2. It is confirmed by histology or cytology (except sputum cytology) to be lung cancer, and according to the International Association for the Study of Lung Cancer (IASLC) eighth edition staging standard, it is evaluated as inoperable or inoperable for radical radiotherapy or inoperable for stage IIIB-IV Locally advanced, recurrent or metastatic subjects who refuse radical radiotherapy; if there are multiple tumor components, they should be classified according to their main cell types; 3. At least one measurable lesion (RECIST 1.1); 4. Subjects must be unsuitable or unwilling to receive radical treatment methods, such as radical radiotherapy and chemotherapy and/or surgery, and have not previously received systemic treatment; 5. ECOG PS score: 0~2 points; the expected survival time is more than 3 months; 6. The main organ functions are normal, and there is no serious blood, heart, lung, liver, kidney dysfunction and immune deficiency diseases, that is, it meets the following standards: (1) The standard of routine blood examination should meet: 1) HB>=90g/L (no blood transfusion within 28 days); 2) ANC >=1.5 x 10^9/L; 3) PLT >=100 x 10^9/L; (2) The biochemical inspection must meet the following standards: 1) TBIL = 30g/L; 5) Cr = 60ml/min; (3) The coagulation function is normal, without active bleeding and thrombosis, and meets the following standards: 1) International standardized ratio INR = lower limit of normal value (50%); 7. The patient voluntarily joined the study, signed an informed consent form, and had good compliance.
Exclusion criteria
Exclusion criteria: 1. Actively infected persons; 2. Immunodeficiency diseases: such as psoriasis, active arthritis, immune nephropathy, HIV, etc. 3. Those without measurable lesions; 4. Patients with cancerous meningitis and spinal cord compression; 5. Active central nervous system (CNS) metastases; CNS metastases who are clinically stable after adequate treatment and maintained for at least 4 weeks can participate in the group; 6. Those who have previously used chemotherapy drugs/targeted drugs/immunotherapy; 7. Clinically severe abnormal gastrointestinal function, which may affect the intake, transport or absorption of the study drug, such as inability to take the drug orally, uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, uncured recurrent diarrhea, Uncured gastric diseases, Crohn's disease, and ulcerative colitis that require long-term use of PPI acid-suppressing drugs; 8. Pulmonary hemorrhage with NCI CTC AE grade> grade 1 occurred within 4 weeks before enrollment; bleeding in other parts with NCI CTC AE grade > grade 2 occurred within 4 weeks before enrollment; hemorrhage tendency (such as active peptic ulcer) Or patients who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or their analogues; Those who have had arterial/venous thrombotic events within 9.6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 10. Patients whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 11. Have received anti-tumor treatments for other malignant tumors in the past, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine (except for malignant tumors that have been cured and have no recurrence and metastasis for >= 5 years); 12. There is uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage (patients who do not need to drain the effusion or stop the drainage for 3 days without a significant increase in effusion can be included in the group). 13. Have used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (that is, no more than 10mg/day splash Nisone or other glucocorticoids in equivalent doses); 14. Known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (Vitiligo or in childhood Asthma has been completely relieved in the early stage, patients who do not need any intervention after adulthood can be included in the group; patients with type I diabetes who have good insulin control can also be included in the group); 15. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 16. Allergic to any component of Anlotinib and monoclonal antibodies; 17. Currently suffering from interstitial lung disease; 18. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 19. Participated in other anti-tumor drug clinical trials within four weeks; 20. Inject anti-infective vaccines (such as influen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival time(PFS);Overall survival;Duration of relief;Objective response rate; | — |
Countries
China
Contacts
Public ContactJi Yinghua
The First Affiliated Hospital of Xinxiang Medical College
Outcome results
None listed