An open-label, randomized, multicentre, phase ? trial of Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers
Not Applicable
Recruiting
- Conditions
- Neoplasms
- Registration Number
- KCT0008772
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 98
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severe neutropenia incidence
- Secondary Outcome Measures
Name Time Method All grades of neutropenia incidence;Incidence of febrile neutropenia;Frequency of unexpected emergency department visits and length of stay;Overall survival;Progression-free survival;Analysis of predictive biomarkers of treatm