Lung cancer
Conditions
Interventions
Experimental group:docetaxel plus sintilimab
Sponsors
the First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient volunteered to participate in the study and signed an informed consent form; 2. Aged 18-75 years old; 3. Pathologically confirmed stage IIIB/IV non-small cell lung cancer (excluding mutations in the EGFR gene and ALK gene) with measurable lesions outside the stomach (RECIST 1.1 standard); 4. ECOG PS score: 0-1 points, estimated survival period >=3 months; 5. The main organ function meets the following criteria within 7 days before treatment: (1) Blood routine examination standard (without blood transfusion within 14 days): Hemoglobin (HB) >=90g/L; The absolute value of neutrophils (ANC) >=1.5x10^9/L; Platelet (PLT) >=80x10^9/L (2) Biochemical tests must meet the following criteria: Total bilirubin (TBIL) =60ml / min.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received immunosuppressive agents, such as Pembrolizumab Nivolumab, Atezolizumab, Avelumab and Durvalumab. 2. Other malignant tumors that have occurred or are currently present in 5 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma) and T1 (tumor infiltrating basement membrane)]; 3. Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C used within 6 weeks prior to receiving the test drug), is planned 4 weeks prior to grouping or during the study period. . Radiation-exposure radiotherapy (EF-RT) was performed within 4 weeks before grouping or tumor-restricted field radiotherapy was performed within 2 weeks before grouping; 4. Unresolved toxicities above CTC AE (4.0) level 1 due to any prior treatment, excluding alopecia and oxaliplatin-induced neurotoxicity =CTC AE grade 2 dyspnea [level 2 dyspnea refers to short breathing during a small amount of activity; affects instrumental activities of daily living]); 7. Patients with any severe and/or uncontrolled disease, including: (1) A patient with antihypertensive drugs is still unsatisfactory (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); (2) Have grade I or higher myocardial ischemia or myocardial infarction, malignant arrhythmia (including QTC >=480ms) and >=grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled serious infection (>=CTC AE grade 2 infection); (4) Cirrhosis, decompensated liver disease, active hepatitis; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) Have a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; (7) Poor diabetes control (fasting blood glucose (FBG)>10mmol/L); (8) Urine routine indicates that urine protein >=++, and confirmed 24-hour urine protein quantitation > 1.0 g; a patient with seizures and requiring treatment; (9) Major surgical treatment, open biopsy or significant traumatic injury within 28 days prior to grouping; Imaging studies have shown that the tumor has invaded the important perivascular circumference or that the patient is likely to invade the important blood vessels during the follow-up study and cause fatal bleeding; (10) Patients with any signs or history of hemorrhage, regardless of severity; patients with any bleeding or bleeding episodes >=CTCAE 3 within 4 weeks prior to grouping, with unhealed wounds, ulcers or fractures; (11) Overactive/venous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate;objective regression rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;quality of life; | — |
Countries
China
Contacts
Public ContactJi-qing HAO
the First Affiliated Hospital of Anhui Medical University
Outcome results
None listed