A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2026-10-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Criteria

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