Overview
To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。
Description
A single-arm, open-label, interventional study was conducted in 25 NSCLC patients with leptomeningeal metastases to observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastases, and to evaluate the incidence and duration of severe neutropenia in the first cycle.
Eligibility
Inclusion Criteria:
- must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender;
- ECOG-PS score of 0-1,and no worsening in the 2 weeks before the study drug;
- expected survival≥12 weeks;
- Advanced non-small cell lung cancer with leptomeningeal metastasis;
- with an Ommaya sac has been implanted;
- At least one measurable lesion meeting RECIST1.1 criteria was present;
- Laboratory tests met the following criteria: hemoglobin ≥100 g/L (female), 110g/L (male) ;neutrophil count ≥ 2×109/L ;platelet count ≥100×109/L; Creatinine ≤ 15mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or 5× ULN (for patients with liver metastases); Albumin ≥ 30 g/L;
- Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
- Voluntarily participate and sign informed consent;
Exclusion Criteria:
- Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
- Stroke or cardio-cerebrovascular event within 6 months before enrollment;
- QTcF interval > 480msec at screening, QTcF > 500msec for patients with implanted ventricular pacemakers;
- Previous hematopoietic stem cell or bone marrow transplantation;
- Allergy to the study drug or its components;
- If the investigator considers that it is not suitable to participate in this study.