Biliary Tract Neoplasms, Pancreatic Neoplasms
Conditions
Brief summary
Evaluate the efficacy and safety of Trilaciclib for myeloprotection prior to chemotherapy in advanced cholangiocarcinoma or pancreatic cancer.
Interventions
DRUGBile 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.
DRUGPancreatic cancer cohort
rilaciclib: 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.
Sponsors
The Second Affiliated Hospital of Shandong First Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade ≥3 Chemotherapy-Induced Neutropenia (CIN) During Chemotherapy Cycles | through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of FN | through study completion, an average of 1 year |
| The incidence of grade ≥ 3 thrombocytopenia | through study completion, an average of 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| OS | 2 years | Throughout the Entire Chemotherapy Course |
| PFS | 1 year | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse |
Contacts
Primary ContactYu E Miao, Doctor
Outcome results
None listed