Clinical trial NCT06151262: A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer
Official title: A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 protocol. Informed consent was signed after full communication. Patients with advanced pancreatic cancer who received first-line treatment were treated with Trilaciclib +mFOLFIRINOX. The incidence of chemotherapy-induced myelosuppression was used as the primary endpoint to observe whether Trilaciclib could reduce the occurrence or degree of chemotherapy-induced myelosuppression.

Eligibility 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

Primary outcomes:
measure: Incidence of CIM
timeFrame: 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）
Secondary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death(up to 24 months)
measure: PFS
timeFrame: From date of first dose of study drug to radiographic disease progression（Up to 24 months）
measure: Safety and Tolerability
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Nanjing University Medical School
name: du juan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: