Non-small cell lung cancer
Conditions
Interventions
one:Tiraizumab + Zadaxin + standard chemotherapy
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) sign written informed consent prior to the implementation of any trial-related process. 2) Aged 18 to 75 years, inclusive. 3) Life expectancy exceeds 3 months. 4) the researchers confirmed at least one measurable lesion according to RECIST1.1 criteria. Measurable lesions located within the field of previous radiotherapy or after local treatment may be selected as target lesions if progression is demonstrated. 5) according to the TNM staging of lung cancer in the 8th edition of the International Association for Lung Cancer Research and the American Joint Committee on Cancer Classification. Class, patients with histologically or cytologically confirmed stage IV or recurrent squamous cell carcinoma or adenocarcinoma NSCLC. 6) the physical fitness score of tumor cooperation group (ECOG) was 0 or 1. 7) Hematological function is sufficient, defined as absolute neutrophil count >= 1.5x10^9 / L, platelet count >= 100x10^9 / L, hemoglobin >= 90g/L (no blood transfusion within 7 days). 8) full liver function, defined as total bilirubin level = 50ml/min (Cockcroft-Gault formula). 10) Coagulation function is sufficient, defined as international standardized ratio (INR) or prothrombin time (PT) <= 1.5 ULN; if the subject is receiving anticoagulant therapy, As long as INR or PT is within the prescribed range of anticoagulants; 11) for female subjects of childbearing age, urine or blood should be presented within 3 days before receiving the first study drug administration. The clear pregnancy test was negative. If the result of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy is required. 12) if there is a risk of conception, male and female patients need to use efficient contraception (that is, the annual failure rate is less than 1%). And lasted for at least 180 days after stopping the trial treatment. Note: abstinence is acceptable as a method of contraception. if abstinence is the subjects' usual lifestyle and preferred method of contraception.
Exclusion criteria
Exclusion criteria: Anyone who occurs one of the following situations will not be selected for this trial. 1) if there are small cell carcinoma, neuroendocrine carcinoma and sarcoma in histology, they can not be included in the group. 2) patients with known EGFR sensitive mutations or ALK rearrangements. 3) currently participating in interventional clinical research or receiving other research drugs or research instruments within 4 weeks before the first administration. 4) there are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis requiring clinical intervention. 5) have received transplantation of solid organs or blood system. 6) there are clinically uncontrollable pleural effusion / peritoneal effusion (patients who do not need drainage or stop drainage for 3 days without a significant increase in effusion can be enrolled in the group). 7) the tumor oppresses the surrounding important organs (such as esophagus) and accompanied by related symptoms, oppresses the superior vena cava or invades the mediastinal vessels, heart, etc. 8) III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias. 9) any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack. History of deep venous thrombosis, pulmonary embolism or any other severe thromboembolism within 3 months before admission (implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism). 10) known allergic reactions to tirelizumab, Ridaxin, pemetrexed, paclitaxel, albumin paclitaxel, carboplatin active ingredients and any excipients. 11) active autoimmune diseases requiring systemic treatment (such as the use of disease improvement drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological dose of corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy. 12) patients who need long-term systemic use of corticosteroids. Patients who need intermittent use of bronchodilators, inhaled corticosteroids, or local injection of corticosteroids due to COPD or asthma can be enrolled. 13) have not fully recovered from the toxicity and / or complications caused by any intervention before starting treatment (i.e., = level 1 or reaching a baseline, excluding fatigue or hair loss). 14) other malignant tumors were diagnosed within 5 years before the first administration, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma and / or radical resection of primary carcinoma. If other malignant tumors or lung cancer are diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent and metastatic lesions should be made. 15) symptomatic central nervous system metastasis. Patients with asymptomatic brain metastases or brain metastases with stable symptoms can participate in this study as long as they meet all the following criteria: there are measurable lesions outside the central nervous system; there is no metastasis of midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord; maintain clinical stability for at least 2 weeks;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival;Disease control rate;time to response;During of response; | — |
Countries
China
Contacts
Public ContactSu Wenmei
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed