NCT06135896RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
* 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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 7 Nov 2023
- Start date
- 16 Jan 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Pancreatic cancer
- NCT number
- NCT06135896
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 98
- From 16 Jan 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu, Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.