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Usefulness of primary long-acting granulocyte colony-stimulating factor in pancreatic cancer patients receiving FOLFIRINOX: A Multicenter Prospective and Retrospective Propensity matching study

Usefulness of primary long-acting granulocyte colony-stimulating factor in pancreatic cancer patients receiving FOLFIRINOX: A Multicenter Prospective and Retrospective Propensity matching study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009465
Enrollment
100
Registered
2024-05-24
Start date
2024-04-15
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Administer eflapegrastim 13.2mg subcutaneously once a month for a total of 4 doses.

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) at initial diagnosis. ? Patients with locally advanced or metastatic pancreatic cancer for whom surgery is not feasible. ? Patients aged 18 years or older.

Exclusion criteria

Exclusion criteria: ? Patients with a history of prior chemotherapy or radiation therapy. ? Patients who discontinued chemotherapy within 2 cycles. ? Patients with a follow-up duration of less than 2 months who have not undergone initial response evaluation. ? Recurrent pancreatic cancer following curative surgery. ? Patients with concurrent or suspected hematologic disorders. ? Patients who have undergone bone marrow or stem cell transplantation previously. ? Patients with autoimmune diseases. ? Patients taking steroids or immunosuppressive agents. ? Patients diagnosed with HIV/AIDS. ? Severe liver or kidney disease. ? Active double primary cancer.

Design outcomes

Primary

MeasureTime frame
Incidence of severe neutropenia (grade III-IV), febrile neutropenia

Secondary

MeasureTime frame
duration of chemotherapy, dose of chemotherapy, survival outcomes, duration of neutropenia, duration of admission due to neutropenic event, duration of antibiotics usage, incidence of infection(cholangitis, liver abscess), UGT1A1 subgroup analysis

Countries

Korea, Republic of

Contacts

Public ContactJiyoung Keum

Ewha Womans University Medical Center

gold8709@gmail.com+82-2-2650-5761

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026