Trilaciclib+mFOLFIRINOX: This was a single-arm, exploratory study of the combination of Trilaciclib and mFOLFIRINOX in patients with advanced pancreatic cancer receiving first-line therapy. Observed the incidence of chemotherapy-induced myelosuppression, and imaging was performed every four cycles to assess tumor response.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of CIM — During treatment. Treatment cycles of 14 days continued from the first dose until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (up to 24 months) Incidence of chemotherapy-induced myelosuppression
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Nanjing University Medical School
Nanjing
Jiangsu
Recruiting
More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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