Reducing severe neutropenia risk in patients with advanced pancreatic and bile duct cancers
Official title: An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Run by National Cancer Center, Korea · NCT06135896 · Data updated 2026-11-12
This study is testing if a new medication can help people with advanced pancreatic and bile duct cancers avoid severe drops in their white blood cell count while they are getting chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 98 (estimated) |
| Sponsor | National Cancer Center, Korea Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Goyang-si, Gyeonggi-do) |
| Status | Recruiting |
| Started | January 16, 2024 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | June 18, 2025 |
| Trial ID | NCT06135896 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 19 and older diagnosed with unresectable pancreaticobiliary cancer who are scheduled to receive specific chemotherapy regimens.
✕Probably not a fit
Patients who have previously experienced severe neutropenia during chemotherapy or those who refuse to participate will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a Phase 2 interventional study aimed at evaluating the effectiveness of tripegfilgrastim in reducing the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers undergoing chemotherapy. The study involves a randomized controlled design with a control group, and patients will be monitored for survival and treatment-related toxicity until disease progression or unacceptable side effects occur. The trial will take place across multiple centers, with follow-up assessments every two months until the end of the trial period in June 2026.
Why it matters
Potential benefit: If successful, this trial could significantly improve the management of neutropenia in patients receiving chemotherapy for advanced pancreaticobiliary cancers, potentially enhancing their treatment outcomes.
How similar studies have gone: Previous studies have shown promising results with similar approaches using granulocyte colony-stimulating factors for neutropenia prevention in cancer patients, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
Goyang-si, Gyeonggi-do, South Korea Recruiting
Study contacts
- Principal investigator: Sangmyung Woo, M.D — National Cancer Center
- Study coordinator: Sangmyung Woo, M.D
- Email: wsm@ncc.re.kr
- Phone: 82-31-920-1733
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.