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

NCT06151262 | Recruiting Phase 2

• 1 other identifier: 2023-419-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• OS

  From date of randomization until the date of death(up to 24 months)

• PFS

  From date of first dose of study drug to radiographic disease progression（Up to 24 months）

• Safety and Tolerability

  Up to 36 months

Study Arms (1)

Trilaciclib+mFOLFIRINOX

EXPERIMENTAL

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.

Drug: Trilaciclib+mFOLFIRINOX

Interventions

Trilaciclib+mFOLFIRINOX DRUG

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.

Also known as: G1T28, CDK 4/6 inhibitor

Trilaciclib+mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• du juan, M.D.

  The Affiliated Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

du juan, M.D.

CONTACT

83106666; dujuanglyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: January 20, 2024
• Primary Completion: May 28, 2025
• Study Completion (Estimated): October 28, 2026
• Last Updated: February 23, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)