Status:
RECRUITING
A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
This study was a single-arm, exploratory clinical study. Patients with advanced pancreatic cancer were screened and enrolled according to the inclusion and exclusion criteria described in the study pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06151262
Start Date
January 20 2024
End Date
October 28 2026
Last Update
February 23 2024
Active Locations (1)
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1
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008