Pancreatic Cancer
Conditions
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.
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.
Interventions
DRUGTrilaciclib+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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CIM | 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） | Incidence of chemotherapy-induced myelosuppression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From date of randomization until the date of death(up to 24 months) | 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) |
| PFS | From date of first dose of study drug to radiographic disease progression（Up to 24 months） | 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. |
| Safety and Tolerability | Up to 36 months | Occurrence and severity of AEs by NCI CTCAE v5.0 |
Countries
China
Contacts
Primary Contactdu juan, M.D.
Outcome results
None listed