RecruitingPhase 2NCT06135896

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

An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

Sponsor

National Cancer Center, Korea

Enrollment

98 participants

Start Date

Jan 16, 2024

Study Type

INTERVENTIONAL

Conditions

Unresectable Pancreatic Cancer Unresectable Bile Duct Carcinoma Unresectable Biliary Tract Carcinoma

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

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial tests tripegfilgrastim — a drug that stimulates white blood cell production — to reduce the risk of severe low white blood cell counts (severe neutropenia) in patients with unresectable pancreatic or bile duct (biliary) cancer receiving a specific chemotherapy regimen called nal-IRI/5-FU/LV. Severe neutropenia increases infection risk and can delay or reduce chemotherapy doses. **You may be eligible if...** - You are 19 or older - You have been diagnosed with unresectable pancreatic or biliary cancer - You are scheduled to receive the nal-IRI/5-FU/LV chemotherapy regimen **You may NOT be eligible if...** - You refuse to sign the consent form - You have previously experienced severe neutropenia (dangerously low white blood cells) during chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTripegfilgrastim

Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers

Locations(1)

NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,

Goyang-si, Gyeonggi-do, South Korea

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NCT06135896

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