resectable stage IIA-IIIA non-small cell lung cancer
Conditions
Interventions
A group:8Gy x Three times radiotherapy of peripheral primary focus
B group:4Gy x Three times radiotherapy of all foci
C group:4Gy x five times radiotherapy of all foci
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily participated in this study, signed informed consent, good compliance, and cooperated with follow-up; 2.Patients with non-small cell lung cancer confirmed by endoscopy and pathology were negative for driver gene; 3.Patients of stage IIA-IIIA in UICC eighth edition; 4.Both men and women are over 18 years old and under 75 years old, including 18 and 75 years old; 5.PS 0-1; 6.There were measurable and / or unmeasurable lesions in accordance with recist1.1; 7.He has not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biotherapy, local therapy and other research and therapeutic drugs); 8.The functions of important organs meet the following requirements (no blood components or cell growth factors are allowed to be used 2 weeks before screening examination) The absolute neutrophil count (ANC) >= 1.5 x 10^9 / L; Platelet >= 100 x 10^9 / L; Hemoglobin >= 9g / dl; Serum albumin >= 2.8g/dL; Total bilirubin = 60 mL / min (calculated according to Cockcroft Gault formula); International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 x ULN (for anticoagulant therapy with stable dose, such as low molecular weight heparin or warfarin, INR can be selected within the expected treatment range of anticoagulant); 9.Female subjects with fertility should conduct urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and prove to be negative, and are willing to use effective contraceptive methods from the trial period to 5 months after the last administration. For male subjects whose partners are women of childbearing age, effective contraceptive methods should be used during the trial period and within 7 months after the last administration.
Exclusion criteria
Exclusion criteria: 1.There was a history of lung cancer surgery; 2.Previous history of fistula caused by primary tumor infiltration; 3.There was a high risk of respiratory tract hemorrhage, tracheal fistula or tracheal perforation; 4.Subjects with poor nutritional status, BMI less than 18.5kg/m^2, or pg-sga score >= 9; 5.Major surgery or severe trauma within 4 weeks before the first use of the study drug; 6.There are uncontrollable pleural effusion, pericardial effusion or ascites that need repeated drainage; 7.Have received or are receiving any of the following treatments in the past: anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy; 8.Received any research drug within 4 weeks before the first use of the research drug; 9.Subjects who need systemic treatment with corticosteroids (> 10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks before the first use of the study drug, except those who use corticosteroids for pulmonary inflammation and prevention of allergy, nausea and vomiting. Other special circumstances need to be communicated with the sponsor. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and corticosteroids with a therapeutic dose of more than 10 mg / day prednisone are allowed; 10.Patients had been vaccinated with anti-tumor vaccine or had been vaccinated with live vaccine within 4 weeks before the first administration of the study drug; 11.Patients with any active autoimmune disease or history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); patients with vitiligo or recovered asthma / allergy of the same year who do not need any intervention in adulthood; use stable dose of thyroid replacement Patients with autoimmune hypothyroidism treated with hormone and type I diabetes treated with stable dose of insulin can be included; 12.Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation; 13.Subjects with uncontrollable clinical cardiac symptoms or diseases, such as (1) heart failure of NYHA II or above (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 14.Severe infection (CTCAE > 2 For example, severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization; baseline chest imaging examination showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, and oral or intravenous antibiotics were required, except for prophylactic use of antibiotics; 15.History of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis or other uncontrolled acute lung diseases; 16.Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within one year before enrollment, or with a history of active pulmonary tuberculosis infection more than one year ago but without regular treatment; 17.The subjects had active hepatitis B (HBV DNA >= 2000 IU / mL or 104 copies / mL) and hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit); 18.There were a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Feasibility; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;Radiographic response;Significant pathological response rate;Progression free survival;Overall Survival;Post-operative complications; | — |
Countries
China
Contacts
Public ContactZhu Xiangzhi
Jiangsu Cancer Hospital
Outcome results
None listed