Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Recruiting
Phase 2
Interventional Study
Unresectable Pancreatic Cancer
Unresectable Bile Duct Carcinoma
Unresectable Biliary Tract Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 98 (estimated)
- Sponsor
- National Cancer Center, Korea · Government
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About This Trial
* 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 dru…
Trial Locations
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Eligibility 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 ex…
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