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

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

• 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborator: Seoul National University Hospital

Criteria

Inclusion Criteria:

• Patients aged at least 19 years old, diagnosed with unresectable pancreaticobiliary cancer, and scheduled to receive chemotherapy using nal-IRI/5-FU/LV combination chemotherapy

Exclusion Criteria:

• Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy