advanced squamous cell lung cancer
Conditions
Interventions
single-arm treatment group:low-dose chemotherapy combined with tirelizumab
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The informed consent has been signed when the age is >=18 years old and =15 mm, scanning layer thickness is not more than 5mm, and the lesions have not received radiotherapy Local treatment such as freezing) 5) Patients with or without symptoms of brain metastasis/meningeal metastasis can be enrolled in the group. Patients with symptomatic brain metastasis/meningeal metastasis need to be studied The researchers thought that local brain treatment was not needed for the time being and the PS score did not decrease significantly within 2 weeks If the patient accepts Transbrain radiotherapy takes more than 1 week from the end of radiotherapy to the beginning of treatment in this study, and the toxicity related to radiotherapy recovers To less than or equal to 1 degree (CTCAE 4.03) (except hair loss) 6) The scores of physical strength in the Eastern Cancer Collaboration Group (ECOG) were 0-2 7) Adequate organ function: A) Hematological function: absolute neutrophil count >= 1.5 × 10 ^ 9/L platelet count >= 80 × 10 ^ 9/L Hemoglobin >= 90 g/L (no blood transfusion history within 7 days and no correction with G-CSF and other hematopoietic factors); B) Liver function is fully defined as total bilirubin level = 50 ml/min (Cockcroft-Gault formula); d) Coagulation function is fully defined as internationalization ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; If the subject is receiving anticoagulant therapy, it is only necessary for INR/PT to be within the prescribed range of anticoagulant drugs 8) Expected survival time greater than 12 weeks 9) Be able to observe adverse events and curative effect cooperatively 10) Negative pregnancy test (only suitable for women with pregnancy possibility) No pregnancy possibility is defined as post At least 1 year or surgical sterilization or hysterectomy/bilateral resection All enrolled patients (male or female) Agree to avoid contraceptive measures within 8 weeks after the end of treatment during the whole treatment period
Exclusion criteria
Exclusion criteria: 1) Any other research drugs were used within 4 weeks before enrollment; 2) Active malignant tumors other than small cell lung cancer within 5 years or at the same time Cured localized tumors such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial carcinoma, carcinoma in situ, carcinoma in situ and breast carcinoma in situ can be included in the group; 3) Subjects have any active autoimmune disease or have a history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, thyroid function (which can be included after alternative therapy); Patients with vitiligo but without intervention in adults can be included; Patients with asthma in childhood who have been completely relieved and can be included without any intervention in adults who still need bronchodilators are not included; 4) Suffering from congenital or acquired immunodeficiency, such as active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower detection limit) or co-infection of hepatitis B and hepatitis C; 5) Use immunosuppressant or systemic therapy within 14 days before starting the study treatment to achieve immunosuppressive purpose (dose > 10mg/day or other therapeutic effects); 6) Patients with uncontrolled cardiac clinical symptoms or diseases such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 7) Complicated with severe infection within 4 weeks before the first time (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs) Or > 38.5 ° C for unknown reasons during screening/before the first administration; 8) The history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known; 9) Vaccination of live attenuated vaccine within 4 weeks before the first administration or planned during the study period; 10) Those who are known to be allergic to any test drug; 11) Pregnant and lactating women who have reproductive ability are unwilling to take effective contraceptive measures; 12) Suffering from uncontrollable mental illness; 13) Other situations that the researcher thinks are not suitable for inclusion Such as symptomatic central nervous system metastasis, severe laboratory examination abnormalities, family or social factors, etc., which will affect the safety of subjects or the collection of data and samples
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;overall survival;disease control rate;Adverse event; | — |
Countries
China
Contacts
Public ContactMin Dong
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed