Actively Recruiting
Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Led by National Cancer Center, Korea · Updated on 2025-06-18
98
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center, Korea
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
* 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
CONDITIONS
Official Title
Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged at least 19 years old
- Diagnosed with unresectable pancreaticobiliary cancer
- Scheduled to receive nal-IRI/5-FU/LV combination chemotherapy
You will not qualify if you...
- Patients who refuse to sign the consent form
- Patients who have previously experienced severe neutropenia during chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
Research Team
S
Sangmyung Woo, M.D
CONTACT
J
Jung Won Chun, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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