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

Not Applicable

Not yet recruiting

• Conditions: Biliary Tract Neoplasms; Pancreatic Neoplasms
• Interventions: Drug: Bile duct cancer cohort; Drug: Pancreatic cancer cohort

• Registration Number: NCT07160283
• Lead Sponsor: The Second Affiliated Hospital of Shandong First Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-16
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study Start: 2025-09-01
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2027-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat	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 chemotherapy are eligible for enrollment.
Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat	Pancreatic 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 chemotherapy are eligible for enrollment.

Primary Outcome Measures

Name	Time	Method
Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cycles	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
The incidence of grade ≥ 3 thrombocytopenia	through study completion, an average of 1 year
The incidence of FN	through study completion, an average of 1 year