non-small cell lung cnacer
Conditions
Interventions
group 1:Vinorelbine, Cisplatin and Sintilimab
group 2:Vinorelbine, Cisplatin, Sintilimab and Bevacizumab
Sponsors
First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1: With my consent and signed informed consent, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures; 2:Age >= 18 years and=3 months; 11: Adequate organ and bone marrow function, defined as: Blood routine test: neutrophil count (ANC) >=1500/MCL; platelet count (PLT) >=100,000/MCL; hemoglobin (Hb) >=9g/dL. Blood biochemistry: serum creatinine (Cr) 50 mL/min(Cockcroft-Gault), glutamic oxalic aminotransferase (AST) and glutamic pyruvic aminotransferase (ALT) levels <=2.5 times the upper limit of normal (ULN), serum total bilirubin <=1.5 times ULN, alkaline phosphatase <=2.5 times ULN, if bone or liver metastasis is combined, AST, ALT and ALP levels =5 times the ULN. Prothrombin time (PT) <=1.5 times ULN; 12: Fertile female subjects must undergo a negative blood pregnancy test during screening and treatment, are not breastfeeding, and must consent to use highly effective contraception during the trial period and within 7 months after the last dosing of the study drug; 13: Male subjects whose partners are fertile women should be surgically sterilized or agree to use highly effective contraception during the trial period and within 4 months after the last dose of the study drug, and sperm donation is not allowed during the study period. In addition, all males are prohibited from donating sperm within one year after receiving the last study treatment infusion.
Exclusion criteria
Exclusion criteria: 1. Has predominantly squamous cell histology NSCLC. Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant small cell component; 2. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the treatment; 3. Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Had major surgery (30 Gray (Gy) within 6 months of the first dose of study medication; 4. Completed palliative radiotherapy within 7 days of the first dose of study medication; 5. Is expected to require any other form of antineoplastic therapy while on study; 6. Received a live-virus vaccination within 30 days of planned start of study medication; 7. Can not swallow pills normally; 8. Suffering from hyperthyroidism or hypothyroidism; 9. Other serious illnesses that may limit subject participation in the study, such as medically uncontrolled diabetes (glycosylated hemoglobin >8%), medically uncontrolled hypertension (blood pressure>160 mmHg/100 mmHg), significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to inclusion, unstable arrhythmias, or unstable angina, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease, or clinically significant pulmonary dysfunction; 10. Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis; 11. Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers; 12. Central nervous system (CNS) metastasis or presence of cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease and/or progressive growth; 13. Known allergy to the investigational drug or excipient, and a history of severe allergic reactions to other monoclonal antibodies; 14. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: Subjects with uveitis, enteritis, hepatitis, pituitaritis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, etc.), hypothyroidism requiring hormone replacement therapy, and skin disorders that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia) may be enrolled; 15. Is on chronic systemic steroids. Except for asthma subjects who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections; 16. Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam); 17. Has an active infection requiring therapy; 18. Has known history of Human Immunodeficiency Virus (HIV); 19. Has known active Hepatitis B or C; 20. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol; 21. Has known psy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactYu Yao
First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed