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

Inclusion criteria

• 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.

Exclusion criteria

• 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.