A Study Of Trilaciclib Combined With MFOLFIRINOX In The Treatment Of Patients With Advanced Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: Trilaciclib+mFOLFIRINOX

2023-419-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-02-21
First Submitted that Met QC Criteria 2023-11-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-23
First Posted (ACTUAL) 2023-11-30	Results First Posted N/A	Last Verified 2023-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Trilaciclib+mFOLFIRINOX 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	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Trilaciclib+mFOLFIRINOX

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

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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)
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）
Safety and Tolerability	Occurrence and severity of AEs by NCI CTCAE v5.0	Up to 36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: du juan, M.D.

Phone Number: 83106666

Email: dujuanglyy@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: du juan, M.D., The Affiliated Hospital of Nanjing University Medical School

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record