A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer
NCT ID: NCT06151262
Last Updated: 2024-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-01-20
2026-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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 treatment were performed every 14 days as a cycle.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Principal Investigators
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du juan, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Nanjing University Medical School
Locations
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The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-419-02
Identifier Type: -
Identifier Source: org_study_id
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