A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of CIM
研究概览
简要总结
To observe the incidence of chemotherapy-induced myelosuppression and the safety of Trilaciclib combined with mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line treatment.
详细描述
This study was a single-arm, exploratory clinical study. Patients with advanced pancreatic cancer were screened and enrolled according to the inclusion and exclusion criteria described in the study protocol. Informed consent was signed after full communication. Patients with advanced pancreatic cancer who received first-line treatment were treated with Trilaciclib +mFOLFIRINOX. The incidence of chemotherapy-induced myelosuppression was used as the primary endpoint to observe whether Trilaciclib could reduce the occurrence or degree of chemotherapy-induced myelosuppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •ECOG score 0 or 1
- •Expected survival≥12 weeks
- •Patients with histologically or cytologically confirmed pancreatic cancer
- •Have not received any antineoplastic therapy prior to treatment
- •Major organ functions within 7 days prior to treatment shall meet the following criteria: a. Neutrophil count ≥1.5×109 /L； b. Hemoglobin ≥10g/dL； c. Platelet count ≥100×109 /L
- •Biochemical examination shall meet the following standards: a、Total bilirubin(TBIL)≤1.5times the upper limit of normal value(ULN); b、ALT and AST≤1.5×ULN ; c、creatinine clearance(CCr)≥60ml/min
- •Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures
- •Subjects voluntarily joined the study and signed an informed consent form(ICF)
- •It is expected that the patient has good compliance and can follow up the efficacy and adverse reactions according to the protocol requirements
排除标准
- •Had received systemic antineoplastic therapy
- •Pregnant and lactating women. Women of childbearing age had to test a negative pregnancy test within 7 days before enrollment
- •Substance abuse, clinical or psychological or social factors that may interfere with informed consent or the conduct of the study
研究组 & 干预措施
Trilaciclib+mFOLFIRINOX
The treatment regimen was as follows:
Trilaciclib 240mg/m2 IV infusion, D1, D2，Q2W； Oxaliplatin 68mg/m2 IV infusion, D1; Irinotecan 135mg/m2 IV infusion D1; leucovorin 400mg/m2 IV infusion D1; 5-FU 2.4g/m2 IV infusion for 46h, D1; A total of 12 cycles of treatment were performed every 14 days as a cycle.
干预措施: Trilaciclib+mFOLFIRINOX (Drug)
结局指标
主要结局
Incidence of CIM
时间窗: During treatment. Treatment cycles of 14 days continued from the first dose until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (up to 24 months）
Incidence of chemotherapy-induced myelosuppression
次要结局
- OS(From date of randomization until the date of death(up to 24 months))
- PFS(From date of first dose of study drug to radiographic disease progression（Up to 24 months）)
- Safety and Tolerability(Up to 36 months)