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Trial Title:
A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer
NCT ID:
NCT06151262
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trilaciclib+mFOLFIRINOX
Description:
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.
Arm group label:
Trilaciclib+mFOLFIRINOX
Other name:
G1T28
Other name:
CDK 4/6 inhibitor
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of Nanjing University Medical School
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Recruiting
Contact:
Last name:
du juan, Doctor
Phone:
83106666
Phone ext:
025
Email:
dujuanglyy@163.com
Start date:
January 20, 2024
Completion date:
October 28, 2026
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151262
