The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer

Обзор

Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.

Вмешательства

• Препарат Bile duct cancer cohort
  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 chemot
• Препарат Pancreatic cancer cohort
  rilaciclib: 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 chemoth

Первичные конечные точки

• Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cycles [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (2)

• The incidence of grade ≥ 3 thrombocytopenia [Срок оценки: through study completion, an average of 1 year]
• The incidence of FN [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07160283 · MT-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗