Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

Condition(s) studied

Investigational drug(s) / intervention(s)

Tripegfilgrastim: Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers

Study summary

* 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

Eligibility

Primary outcome measure(s)

• Primary endpoint — through study completion, an average of 1 year
  Severe neutropenia incidence

Trial sites (1)

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