The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 主要终点
- Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cycles
研究概览
简要总结
Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years, male or female.
- •Pathologically confirmed diagnosis of cholangiocarcinoma or pancreatic cancer requiring chemotherapy-based treatment.
- •ECOG performance status ≥0 (or 1), anticipated survival ≥3 months, and ability to complete ≥3 months of follow-up.
- •No clinically significant abnormalities in complete blood count, hepatic/renal function, cardiac enzymes, or electrocardiogram (ECG).
- •Voluntary participation with good compliance and willingness to undergo safety and survival follow-up.
- •Signed written informed consent form prior to enrollment.
排除标准
- •History of myeloid leukemia, myelodysplastic syndrome, or concurrent sickle cell disease.
- •Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiotherapy or steroid therapy.
- •Major surgery or radiotherapy within 4 weeks prior to the first dose of study drug.
- •History of interstitial lung disease, slowly progressive dyspnea with dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, multiple allergies, or peripheral arterial disease.
- •Concurrent requirement for radiotherapy.
- •Known hypersensitivity to any component of the study drug formulation.
- •Pregnancy or lactation.
- •Any other condition deemed by the investigator to compromise patient safety or study validity.
研究组 & 干预措施
Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat
Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day.
Chemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information.
Subjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment.
干预措施: Bile duct cancer cohort (Drug)
Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat
Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day.
Chemotherapy Agents: Investigators will select chemotherapy regimens based on individual patient status. Regimens must be single-day protocols (including but not limited to gemcitabine, nab-paclitaxel, etc.), with dosing and administration per prescribing information.
Subjects receiving concomitant immunotherapy or targeted therapy in addition to chemotherapy are eligible for enrollment.
干预措施: Pancreatic cancer cohort (Drug)
结局指标
主要结局
Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cycles
时间窗: through study completion, an average of 1 year
次要结局
- The incidence of grade ≥ 3 thrombocytopenia(through study completion, an average of 1 year)
- The incidence of FN(through study completion, an average of 1 year)