lung cancer
Conditions
Interventions
S1:S1 maintenance treatment
BSC:BSC
Sponsors
The first affiliated hospital of Guilin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) histologically diagnosed advanced lung squamous cell carcinoma (IIIB or IV), according to the American Cancer Staging Standard Joint Committee definition is not suitable for radical treatment, EGFR gene mutation for the wild type or unknown type, the preferred chemotherapy as first-line treatment; 2) The patient has at least one measurable lesion present. According to RECIST 1.1, the measurable lesion is defined as a method of accurately measuring at least one diameter of the lesion by conventional methods: measuring lesion diameter = 20 mm or using a spiral CT to measure lesion diameter = 10 mm. Positron emission tomography (PET) and ultrasound can not be used as a measure of the lesion; 3) Patients must have previously had no chemotherapy or molecular targeted therapy for advanced disease and more than 6 months after the end of adjuvant or neoadjuvant chemotherapy. Radiotherapy of local lesions can not be included in the measurable lesion unless recorded after the last radiotherapy Significant progress has been made in this lesion; 4) Patients who have previously undergone surgery may be enrolled, but must be restored according to the researcher's evaluation and the time of surgery is completed for at least 4 weeks from the study; 5) Eastern Cancer Cooperative Group (ECOG) scale physical condition in 0 to 2 points; 6) expected survival expectancy> 6 months, with follow-up conditions; 7) no serious cardiopulmonary disease; 8) organ functional level must meet the following requirements: Adequate bone marrow reserve: neutrophils (lobular and zonal nuclear neutrophils) absolute count (ANC) count = 1.5x109/L, platelet =100x10^9/L, and hemoglobin = 80g/L. Liver: bilirubin <1.5 times the upper limit of normal, alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 times the upper limit of normal (if liver metastases allow ALP , AST, ALT <5 times the upper limit of normal); Kidney: Calculate creatinine clearance = 60 mL/min (using the standard Cockcroft-Gault formula); 9) Aged 18 to 75 years; 10) patients provided written informed consent before enrollment.
Exclusion criteria
Exclusion criteria: 1) patients with clear or suspected brain metastases. Patients suspected of brain metastases clinical symptoms and signs should be in the group before the brain CT or MRI examination. Patients with previous history of brain metastases must have completed treatment, asymptomatic and no longer need corticosteroid patients can be grouped; 2) patients have cognitive dysfunction; 3) the presence of chemotherapy contraindications patients: such as severe bone marrow dysfunction, bleeding tendency, active infection, 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, Immunosuppressive therapy; 4) Pregnancy, lactation, or fertility but not taking contraceptive measures for female patients; 5) patients abuse of drugs or alcohol addicts; 6) patients known to have an allergic reaction to any of the drugs in the study; 7) patients who do not have regular follow-up conditions; 8) other patients that are inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS1; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS2;The OS of maintenance treatment;OS; | — |
Countries
China
Contacts
Public ContactHe Shaozhong
The first affiliated hospital of Guilin Medical University
Outcome results
None listed