A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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 Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 of trilaciclib [Up to 36 months]
Occurrence and severity of AEs by NCI CTCAE v5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
- 1、Age 18-75 years； 2、ECOG score 0 or 1; 3、Expected survival≥12 weeks； 4、Patients with histologically or cytologically confirmed pancreatic cancer； 5、Have not received any antineoplastic therapy prior to treatment. 6、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 ； 7、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; 8、Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures; 9、Subjects voluntarily joined the study and signed an informed consent form(ICF); 10、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:
-1、Had received systemic antineoplastic therapy； 2、Pregnant and lactating women. Women of childbearing age had to test a negative pregnancy test within 7 days before enrollment.
3、Substance abuse, clinical or psychological or social factors that may interfere with informed consent or the conduct of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China | 210008 |
Sponsors and Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
- Principal Investigator: du juan, M.D., The Affiliated Hospital of Nanjing University Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-419-02