Low-dose Gemcitabine Combined With Nivolumab for Second-line and Above Line Treatment of NSCLC
Non-small Cell Lung Cancer Metastatic
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer Metastatic focused on measuring PD - 1 antibodies, Low-dose Gemcitabine, Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- the patient voluntarily participated in the study and signed the informed consent;
- advanced non-small cell lung cancer with negative driving gene confirmed by pathology has at least one measurable focus.
- in the last 6 months, chemotherapy failed;
- 18-70 years old; ECoG PS score 0-1; estimated survival time over 3 months;
within 7 days before treatment, the main organ functions meet the following standards:
blood routine examination standard (without blood transfusion within 14 days):
A) hemoglobin (HB) ≥ 90g / L;
B) neutrophil absolute value (ANC) ≥ 1.5 × 109 / L;
C) platelet (PLT) ≥ 80 × 109 / L
biochemical examination shall meet the following standards:
A) TBIL ≤ 1.5 times the upper limit of normal value (ULN);
B) ALT and AST ≤ 2.5 × ULN, if with liver metastasis, ALT and AST ≤ 5 × ULN;
C) Cr ≤ 1.5 × ULN or CCR ≥ 60ml / min;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%).
- women of childbearing age shall agree to use contraceptive measures (such as IUD, contraceptive pill or condom) during the study and within 6 months after the end of the study; women of childbearing age shall agree to use contraceptive measures during the study and within 6 months after the end of the study (such as IUD, contraceptive pill or condom); women of childbearing age shall agree to use contraceptive measures during the study and 6 months after the end of the study if their pregnancy test is negative within 7 days before the study.
Exclusion Criteria:
- patients who have used PD-1 antibody of other companies before;
- with pleural effusion or ascites, it causes respiratory syndrome (≥ CTC AE Level 2 dyspnea);
- unresponsive toxic reactions higher than level 1 of CTC AE (4.0) caused by any previous treatment, excluding hair loss;
patients with any serious and / or uncontrolled disease, including:
- patients with myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QTc ≥ 480ms) and congestive heart failure ≥ grade 2 (NYHA classification);
- active or uncontrollable severe infection (≥ CTC AE Level 2 infection);
- renal failure needs hemodialysis or peritoneal dialysis;
patients with any serious and / or uncontrolled disease, including:
- have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- poor control of diabetes mellitus (FBG > 10mmol / L);
- routine urine test indicated that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 G;
- patients with epilepsy who need treatment;
- received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the group;
- those who have a history of psychoactive drug abuse and are unable to quit or have mental disorders;
- participated in clinical trials of other anti-tumor drugs within four weeks;
Sites / Locations
Arms of the Study
Arm 1
Experimental
Low-dose Gemcitabine Combined With nivolumab
Bristol-myers squibb (BMS) company's nivolumab injection liquid (trade name: odiwal). Recommended dosage: 3mg/kg, intravenously injected once every 2 weeks for 60 minutes. As long as clinical benefit is observed, continue treatment with this product for up to 6 courses. Gemcitabine hydrochloride injection from eli lilly. Use 50% of the recommended dose, i.e. 500mg/m2, intravenously for 30 minutes. Day 1 and day 8 administration. Depending on the patient's tolerance to gemcitabine, a reduced dose may be considered for each treatment cycle or one treatment cycle. Use for 1 year. If a Ⅲ magnitude of adverse reactions, it is necessary to permanently discontinued.