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Clinical Trials in China / NCT06151262
Recruiting Phase 2

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

NCT06151262 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase
Phase 2
Started
2024-01-20
Last updated
2024-02-23

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

Trilaciclib+mFOLFIRINOXAll Trilaciclib trials (10) →All MFOLFIRINOX trials (14) →

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)

Trial sites (1)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06151262 on ClinicalTrials.gov ↗ ← All trials in China