Non-small cell lung cancer
Conditions
Interventions
Study group:After radiotherapy treatment, maintenance therapy was administered with apalolitovolrelimab
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, gender not limited; 2. According to the 8th edition of AJCC staging, for newly diagnosed NSCLC patients at stage IIA-?C who have been confirmed by histopathology/cytology and are unable or unwilling to undergo surgery, SBRT irradiation is feasible after clinical assessment. 3. According to the response evaluation criteria for Solid tumors (RECIST 1.1), there is at least one measurable lesion; 4. ECOG score: 0-2 points; 5. Sufficient organ function, laboratory tests meet the following standards: Blood routine test (1)Hemoglobin>=90g/L ; (2) Absolute neutrophil count >=1.5×10^9/L (3)Platelet count >=100×10^9/L; Biochemical test (1)Serum albumin>=30g/L; (2)Alt and AST=50mL/min; 6. Expected survival period >=12 weeks; 7. Voluntarily sign the informed consent form and be able to understand and comply with the research requirements to complete the study.
Exclusion criteria
Exclusion criteria: 1. Allergy to the test drug and its excipients; 2. Had received other anti-tumor drug treatments within 4 weeks prior to the first day of the study, or had not yet recovered from adverse events caused by drugs administered 4 weeks ago; 3. Known EGFR and/or ALK mutations; 4. Patients with active brain metastases; 5. Having suffered from other malignant tumors in the past five years, except for those that have been completely cured; 6. Those with any active, known or suspected autoimmune diseases; 7. Subjects who have received systemic treatment with corticosteroids (more than 10 days of prednisone or other equivalent hormones) or other immunosuppressants within one month prior to screening; 8. Have undergone major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study treatment or are expected to undergo major surgical treatment during the study period; 9. Any severe acute or chronic infection (except viral hepatitis) with a history of myocardial infarction or heart failure that requires systemic antibacterial, antifungal or antiviral treatment; Patients with a history of interstitial lung disease; 11. Pregnant, preconception and lactating women; 12. Researchers evaluated patients with poor compliance who could not guarantee treatment and follow-up according to the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response ratio, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS;Disease control rate, DCR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactBo Changwen
The First Hospital of Hebei Medical University
Outcome results
None listed