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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Affiliated Hospital of Shandong First Medical University

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bile duct cancer cohort
  • Pancreatic cancer cohort

Treatment groups

96 Participants
are divided into 1 treatment group

Locations

This trial has no locations