An open-label, randomized, multicentre, phase ? trial of Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0008772

Enrollment

Registered

2023-09-07

Start date

2024-01-16

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Treatment Group: -Premedication: depending on the center (Ondansetron 8 mg +Dextrose 5% 50 mL, MIV, Dexamethasone 10 mg IV, and Atropine sulfate 0.25 mg [0.5 amp] SC) -Onivyde 70 mg/m2 + Dextro

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy

Design outcomes

Primary

Measure	Time frame
Severe neutropenia incidence	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJihye Yu

National Cancer Center

73615@ncc.re.kr+82-31-920-0750

Outcome results