A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer
Recruiting · NCT06151262 · Interventional (participants receive a specific treatment) · Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
View the official record on ClinicalTrials.gov →Interventions studied
Trilaciclib+mFOLFIRINOX
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- The Affiliated Hospital of Nanjing University Medical School - Nanjing, Jiangsu, China