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

The Second Affiliated Hospital of Shandong First Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Biliary Tract Neoplasms; Pancreatic Neoplasms

Treatments: Drug: Pancreatic cancer cohort; Drug: Bile duct cancer cohort

Study type: Interventional

Funder types: Other

Identifiers

NCT07160283

MT-008

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Trilaciclib combined with chemotherapy for the treatment of advanced cholangiocarcinoma and pancreat

Experimental group

Description:

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.

Treatment:

Drug: Bile duct cancer cohort

Drug: Pancreatic cancer cohort