Clinical trial · Interventional
A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer
A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer
NCT06151262CI-TRIAL-00074320recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trilaciclib+mFOLFIRINOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trilaciclib+mFOLFIRINOX
- description
- 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.
- interventionNames
- Drug: Trilaciclib+mFOLFIRINOX
Primary outcomes (1)
- measure
- Incidence of CIM
- timeFrame
- 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）
- description
- Incidence of chemotherapy-induced myelosuppression
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.