lung cancer
Conditions
Interventions
single arm:Carelizumab 200 mg, D1-14, Q2W
Sponsors
The Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects volunteered to join the study, signed the informed consent, good compliance, and cooperated with the visit; 2. Aged >= 18 years (calculated on the day of signing informed consent) ;aged <= 75 years; 3. Patients with advanced NSCLC confirmed by histopathology and/or cytology; 4. The patient had at least one measurable lesion (iRECIST 1.1); 5. The expected survival time is more than 12 weeks; 6. ECOG PS 0-2 ?.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.For target observation group, exclude patients suffering from immune system diseases and lung diseases: 1)Patients with active autoimmune diseases; 2)Patients with a history of chronic or recurrent autoimmune diseases; 3)Patients with interstitial lung disease or pulmonary fibrosis; 4)Patients with a history of pneumonia treated with glucocorticoids 3.Patients with a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding within the past 6 months, such as esophageal varices at risk of bleeding, locally active ulcer lesions, fecal occult blood >= (++), should not be enrolled in the group; if fecal occult blood (+), gastroscopy is required; 4.Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study; 5.Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), prone to bleeding or undergoing thrombolytic or anticoagulant therapy; 6.Urine routine showed urinary protein >= (++) or confirmed 24-hour urinary protein quantification > 1.0 g; 7.Received strong CYP3A4 inhibitor treatment within 7 days before participating in the study or strong CYP3A4 inducer treatment within 12 days before participating in the study; 8.According to the judgement of the researcher, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DoR;RFS;DCR;OS;QOL; | — |
Countries
China
Contacts
Public ContactRuiling Ning
The Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed