A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer

2023-419-02

To observe the incidence of chemotherapy-induced myelosuppression and the safety of Trilaciclib combined with mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line treatment.

2024-01-20

2025-05-28

2026-10-28

Recruiting

Early phase I

30

Inclusion Criteria: * Age 18-75 years * ECOG score 0 or 1 * Expected survival≥12 weeks * Patients with histologically or cytologically confirmed pancreatic cancer * Have not received any antineoplastic therapy prior to treatment * Major organ functions within 7 days prior to treatment shall meet the following criteria: a. Neutrophil count ≥1.5×109 /L； b. Hemoglobin ≥10g/dL； c. Platelet count ≥100×109 /L * Biochemical examination shall meet the following standards: a、Total bilirubin(TBIL)≤1.5times the upper limit of normal value(ULN); b、ALT and AST≤1.5×ULN ; c、creatinine clearance(CCr)≥60ml/min * Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures * Subjects voluntarily joined the study and signed an informed consent form(ICF) * It is expected that the patient has good compliance and can follow up the efficacy and adverse reactions according to the protocol requirements Exclusion Criteria: * Had received systemic antineoplastic therapy * Pregnant and lactating women. Women of childbearing age had to test a negative pregnancy test within 7 days before enrollment * Substance abuse, clinical or psychological or social factors that may interfere with informed consent or the conduct of the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-02-23