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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151262
• Other study ID #: 2023-419-02
• Status: Recruiting
• Phase: Phase 2
• Start date: January 20, 2024
• Est. completion date: October 28, 2026

Study information

• Verified date: October 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: du juan, M.D.
• Phone: 83106666
• Email: dujuanglyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 28, 2026
• Est. primary completion date: May 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CIM	Incidence of chemotherapy-induced myelosuppression	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	OS	Overall survival defined as time from the date of first dose of study drug to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)	From date of randomization until the date of death(up to 24 months)
Secondary	PFS	Progression-free survival (PFS per RECIST 1.1) is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.	From date of first dose of study drug to radiographic disease progression(Up to 24 months)
Secondary	Safety and Tolerability	Occurrence and severity of AEs by NCI CTCAE v5.0	Up to 36 months