Non-Small-Cell Lung Cancer
Conditions
Interventions
experimental group:sequential Hypofractionated IMRT combined with Toripalimab
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients willing and signing informed consent; 2. Patients aged 18-80 (including boundary value), regardless of gender; 3. The stage of non-small cell lung cancer that can not be operated on is IIIA, IIIB or IIIc; 4. Patients without previous history of malignant tumor; 5. Patients with ECoG physical strength score of 0-2; 6. The hematological indexes were basically normal: neutrophil absolute value >= 1.5x10^9/l, platelet >= 100 x 10^9 / L, hemoglobin >= 90g / L; 7. liver function is basically normal: total bilirubin = 60ml / min; 9. Coagulation function is basically normal: INR <= 1.5; ten Patients of childbearing age (both men and women) are willing to contraception (including but not limited to hormone contraception, physical contraception or abstinence) between the signing of informed consent and 30 days after the last dose of study treatment; 10. Women of childbearing age are negative in pregnancy test within 1 day before the first dose of study drug treatment is planned; and men are willing to contraception from the beginning of study treatment to the last dose of study Sperm donation was not allowed for 90 days after treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with primary tumor > 7cm; 2. Patients whose primary tumor or metastatic lymph node is not less than 4cm away from the head and foot of esophagus; 3. Patients with obstruction caused by primary tumor and metastatic lymph nodes surrounding the esophagus or invading the esophagus; 4. Patients who have received any antibody / drug (including PD-1, PD-L1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint); 5. Patients who have active or have had autoimmune diseases that may recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or have such risks (e.g. they need immunosuppressive treatment for organ transplantation). However, subjects with the following diseases are allowed to further enter the group for screening: type I diabetes, hypothyroidism requiring hormone replacement only, skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or it is expected that the disease will not recur without external triggers; 6. Patients diagnosed with immunodeficiency or who received systemic hormone therapy within 14 days before treatment (e.g., hormone therapy equivalent to > 10 mg prednisone per day) or who used any other form of immunosuppressive therapy. Note: if the subject does not have active autoimmune disease, hormone equivalent to <= 10 mg prednisone per day is allowed as adrenal replacement therapy. Subjects were allowed to use local, ophthalmic, intraarticular, intranasal and inhaled corticosteroids (very low systemic absorption). The use of short-term glucocorticoids is allowed for the prevention (e.g. for contrast allergy) or treatment of non autoimmune diseases (e.g. delayed type hypersensitivity caused by contrast allergy); 7. Patients with interstitial lung disease and symptoms of the disease; subjects who believe that previous pulmonary history may interfere with the judgment or treatment of drug-related pulmonary toxicity also need to be excluded; 8. Patients with active tuberculosis infection history within one year before the first administration of the study drug, and subjects with active tuberculosis infection history more than one year ago, if the researcher judges that there is no evidence of active tuberculosis at present, they are considered suitable for inclusion; 9. Patients with a history of or present with inflammatory bowel disease (such as Crohn's disease and ulcerative colitis). 10. Patients with known history of human immunodeficiency virus (HIV) infection and / or acquired immunodeficiency syndrome; 11. Subjects with active hepatitis B or active hepatitis C. In the screening period, the subjects with HBsAg positive or HCV antibody positive must further pass the quantitative detection of HBV DNA (excluding more than 2500 copies [CPS] / ml or 500 IU / ml) and HCV RNA detection (excluding exceeding the detection limit of the detection method), after excluding the active hepatitis B or hepatitis C infection to be treated, can be included in the group test. Hepatitis B virus carriers, stable hepatitis B after drug treatment (DNA titer shall not be higher than 2500 copies [CPS] / ml or 500 IU / ml) and cured hepatitis C subjects can be included in the group; 12. Patients who have received organ transplantation; 13. Patients with a known history of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;Adverse reactions; | — |
Countries
China
Contacts
Public ContactZhu Xiangzhi
Jiangsu Cancer Hospital
Outcome results
None listed