Combining Trilaciclib with mFOLFIRINOX for advanced pancreatic cancer treatment

A Single-arm, Exploratory Clinical Study of Trilaciclib Combined With mFOLFIRINOX Regimen in the Treatment of Patients With Advanced Pancreatic Cancer

This study is testing if adding Trilaciclib to standard chemotherapy can help people with advanced pancreatic cancer avoid some of the harmful side effects of treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06151262 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of Trilaciclib when combined with mFOLFIRINOX in patients with advanced pancreatic cancer who are receiving first-line chemotherapy. It is a single-arm, exploratory study that aims to observe the incidence of chemotherapy-induced myelosuppression, which is a common side effect of cancer treatment. Patients will be screened and enrolled based on specific inclusion and exclusion criteria, and their responses to the treatment will be monitored closely. The primary endpoint is to determine whether Trilaciclib can reduce the occurrence or severity of myelosuppression during treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with histologically confirmed advanced pancreatic cancer who have not previously received antineoplastic therapy.

Not a fit: Patients who have received prior systemic therapy for pancreatic cancer or have major organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could significantly improve the quality of life for patients by reducing chemotherapy-related side effects.

How similar studies have performed: While this approach is exploratory, similar studies combining supportive therapies with chemotherapy have shown promise in reducing side effects, suggesting potential for success.

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

Where this trial is running

Nanjing, Jiangsu

• The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: du juan, M.D. — The Affiliated Hospital of Nanjing University Medical School
• Study coordinator: du juan, M.D.

Conditions Pancreatic Cancer