Status:
UNKNOWN
Low-dose Gemcitabine Combined With Nivolumab for Second-line and Above Line Treatment of NSCLC
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Non-small Cell Lung Cancer Metastatic
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tum...
Detailed Description
In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tum...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04331626
Start Date
April 1 2020
End Date
April 1 2023
Last Update
April 2 2020
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