NCT06151262

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

A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-01-20
• Primary completion: 2025-05-28
• Completion: 2026-10-28
• First posted: 2023-11-30
• Last updated: 2024-02-23

Locations

1 site across 1 country: China