NSCLC
Conditions
Interventions
Experimental group:Target volume delineation based on immune protection
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form. At the time of signing, male or female participants must be aged 18 years or older; 2. Able to comply with the study protocol; 3. Histologically or cytologically confirmed non-small cell lung cancer; 4. Stage IIIA, IIIB, or IIIC according to the 9th edition TNM cancer staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC); 5. Unresectable after induction immunotherapy and chemotherapy or refuse surgery; 6. ECOG performance status score of 0–2; 7. Expected survival of at least 6 months; 8. All toxicities from prior anti-tumor therapy must have recovered to = 1.5 × 10^9/L; platelet count >= 100 × 10^9/L; hemoglobin >= 90 g/L; (2) Liver function: total bilirubin = 60 mL/min (Cockcroft-Gault); urinalysis showing protein = 2, 24-hour urine protein quantification should be < 1 g; (4) Coagulation: international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN; if the subject is on anticoagulant therapy, PT should be within the intended range for the anticoagulant; 10. Female participants of childbearing potential must agree to use effective contraception during the trial and for 6 months after the last dose, and must have a negative pregnancy test before starting treatment; 11. Male participants must agree to use effective contraception during the trial and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Tumor progression after immunotherapy and chemotherapy; 2. EGFR, ALK, or ROS1 mutations; 3. Previous chest radiotherapy; 4. Grade 2 or higher immune-related adverse events following induction immunotherapy; 5. Major surgery within 4 weeks prior to the first dose of study treatment or expected need for major surgery during the study treatment; 6. Active autoimmune disease or history of autoimmune disease with potential for recurrence; 7. Patients requiring long-term systemic corticosteroids. Patients who intermittently use bronchodilators, inhaled corticosteroids for COPD or asthma, or locally injected corticosteroids can be included; 8. Subjects with active chronic hepatitis B or hepatitis C (HBsAg positive but HBV-DNA <= upper limit of normal, HCV-Ab positive but HCV-RNA <= upper limit of normal can be included); 9. History of organ transplantation; 10. Known human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 11. Any other malignant tumor within the past 2 years (except clinically cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin); 12. Any clinically significant gastrointestinal dysfunction, history of inflammatory bowel disease, or current inflammatory bowel disease (such as Crohn's disease or ulcerative colitis); 13. Pregnant or breastfeeding women; 14. Subjects deemed by the investigator to be unsuitable for participation due to any clinical or laboratory abnormalities or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Objective Response Rate (ORR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactHong Fu
Anhui Provincial Cancer Hospital
Outcome results
None listed