Status:
NOT_YET_RECRUITING
The Efficacy and Safety of Trilaciclib in Bone Marrow Protection Before Chemotherapy for Advanced Bile Duct Cancer and Pancreatic Cancer
Lead Sponsor:
The Second Affiliated Hospital of Shandong First Medical University
Conditions:
Biliary Tract Neoplasms
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT07160283
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 8 2025
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