An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
RECRUITING
Goyang-si
Contact Information
Primary
Sangmyung Woo, M.D
wsm@ncc.re.kr
82-31-920-1733
Backup
Jung Won Chun, M.D
deli4928@ncc.re.kr
82-31-920-0887
Time Frame
Start Date:2024-01-16
Estimated Completion Date:2026-06-30
Participants
Target number of participants:98
Treatments
Experimental: Treatment Group
* Premedication: depending on the center (Ondansetron 8 mg +Dextrose 5% 50 mL, MIV, Dexamethason 10 mg IV, and Atropine sulfate 0.25 mg \[0.5 amp\] SC)~* Onivyde 70 mg/m2 + Dextrose 5% 500 mL (bag), and MIV for 90 min~* Leucovorin 400 mg/m2 + Dextrose 5% 500 mL (bag), and MIV for 30 min~* 5-FU (2400 mg/m2) + Dextrose 5% 500 mL (bag) and MIV for 46 h~* Tripegfilgrastim 6 mg SC administered 24 h after completing 5-FU infusion The above chemotherapy will be administered every two weeks
No_intervention: Control Group
* Premedication: depending on center (Ondansetron 8 mg+Dextrose 5% 50 mL, MIV, Dexamethason 10 mg IV, and Atropine sulfate 0.25 mg \[0.5 amp\] SC)~* Onivyde 70 mg/m2 + Dextrose 5% 500 mL (bag), and MIV for 90 min~* Leucovorin 400 mg/m2 + Dextrose 5% 500 mL (bag), and MIV for 30 min~* 5-FU (2400 mg/m2) + Dextrose 5% 500 mL (bag), and MIV for 46 h The following medication will be provided in the event that the patient develops febrile neutropenia after the above chemotherapy~* Tripegfilgrastim 6 mg SC administered 24 h after stopping 5-FU. In the event of neutropenia, chemotherapy will be paused until the patient recovers, and then restarted after recovery.~* The above chemotherapy will be administered every two weeks.