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

Nanjing University

Status and phase: Enrolling; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Trilaciclib+mFOLFIRINOX

Study type: Interventional

Funder types: Other

Identifiers

NCT06151262

2023-419-02

Details and patient eligibility

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Trilaciclib+mFOLFIRINOX

Experimental group

Description:

The treatment regimen was as follows: Trilaciclib 240mg/m2 IV infusion, D1, D2，Q2W； Oxaliplatin 68mg/m2 IV infusion, D1; Irinotecan 135mg/m2 IV infusion D1; leucovorin 400mg/m2 IV infusion D1; 5-FU 2.4g/m2 IV infusion for 46h, D1; A total of 12 cycles of treatment were performed every 14 days as a cycle.

Treatment:

Drug: Trilaciclib+mFOLFIRINOX