Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

* Clinical trial phase: Phase 2 * Intervention model: Control group * Group allocation: Randomized controlled trial * Research perspective: Prospective study * Participating centers: Multicenter study * Definition of the intervention period: Based on the RECIST 1.1 guidelines, patients will receive treatment until dropout due to disease progression or unacceptable toxicity related to the trial drug. Patients will be followed up with to assess survival every 2 months until either death or the end of the trial, whichever is first. * The intervention period is from the date of IRB approval to December 31st, 2025 * The follow-up duration is one year, and the statistical analysis duration is six months * The total research period is from the date of IRB approval to June 30th, 2026

NCT Number	NCT06135896
Lead Sponsor	National Cancer Center, Korea Collaborators: Seoul National University Hospital
Conditions	Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract Carcinoma
Enrollment	98 participants
Start Date	2024-01-16
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-06-18