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

Recruiting now · Phase 2

Conditions studied: Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract Carcinoma

In brief

* 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

Key facts

Study ID

NCT06135896

Run by

National Cancer Center, Korea

People needed

98

Starts

2024-01-16

Expected to finish

2026-06-30

Last updated by the study team

2025-06-18

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu, — Goyang-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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