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

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

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

Inclusion Criteria:

1. Age >18 years, male or female.
2. Pathologically confirmed diagnosis of cholangiocarcinoma or pancreatic cancer requiring chemotherapy-based treatment.
3. ECOG performance status ≥0 (or 1), anticipated survival ≥3 months, and ability to complete ≥3 months of follow-up.
4. No clinically significant abnormalities in complete blood count, hepatic/renal function, cardiac enzymes, or electrocardiogram (ECG).
5. Voluntary participation with good compliance and willingness to undergo safety and survival follow-up.
6. Signed written informed consent form prior to enrollment.

Exclusion Criteria:

1. History of myeloid leukemia, myelodysplastic syndrome, or concurrent sickle cell disease.
2. Symptomatic CNS metastases and/or leptomeningeal disease requiring immediate radiotherapy or steroid therapy.
3. Major surgery or radiotherapy within 4 weeks prior to the first dose of study drug.
4. 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.
5. Concurrent requirement for radiotherapy.
6. Known hypersensitivity to any component of the study drug formulation.
7. Pregnancy or lactation.
8. Any other condition deemed by the investigator to compromise patient safety or study validity.