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

NCT06135896 | Recruiting Phase 2

• 1 other identifier: NCC2023-0235
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Unresectable Pancreatic Cancer; Unresectable Bile Duct Carcinoma; Unresectable Biliary Tract Carcinoma

Keywords

Unresectable Pancreatic Cancer; Unresectable Bile Duct Carcinoma; Unresectable Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  Severe neutropenia incidence

  through study completion, an average of 1 year

Secondary Outcomes (6)

• neutropenia incidence

  through study completion, an average of 1 year

• Febrile neutropenia

  through study completion, an average of 1 year

• emergency department visits

  through study completion, an average of 1 year

• Overall survival

  through study completion, an average of 1 year

• Progression-free survival

  through study completion, an average of 1 year

Study Arms (2)

Treatment Group

EXPERIMENTAL

* 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

Drug: Tripegfilgrastim

Control Group

NO INTERVENTION

* 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.

Interventions

Tripegfilgrastim DRUG

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

Also known as: Dulastin

Treatment Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

Related Publications (13)

• Kang MJ, Lim J, Han SS, Park HM, Kim SW, Lee WJ, Woo SM, Kim TH, Won YJ, Park SJ. Distinct prognosis of biliary tract cancer according to tumor location, stage, and treatment: a population-based study. Sci Rep. 2022 Jun 17;12(1):10206. doi: 10.1038/s41598-022-13605-3.

  PMID: 35715440 RESULT

• Canton C, Boussari O, Boulin M, Le Malicot K, Taieb J, Dahan L, Lopez A, Lepage C, Bachet JB. Impact of G-CSF Prophylaxis on Chemotherapy Dose-Intensity, Link Between Dose-Intensity and Survival in Patients with Metastatic Pancreatic Adenocarcinoma. Oncologist. 2022 Jul 5;27(7):e571-e579. doi: 10.1093/oncolo/oyac055.

  PMID: 35289915 RESULT

• Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270.

  PMID: 30998813 RESULT

• Yoo C, Im HS, Kim KP, Oh DY, Lee KH, Chon HJ, Kim JH, Kang M, Kim I, Lee GJ, Oh SY, Choi Y, Choi HJ, Kim ST, Park JO, Ryoo BY. Real-world efficacy and safety of liposomal irinotecan plus fluorouracil/leucovorin in patients with metastatic pancreatic adenocarcinoma: a study by the Korean Cancer Study Group. Ther Adv Med Oncol. 2019 Aug 23;11:1758835919871126. doi: 10.1177/1758835919871126. eCollection 2019.

  PMID: 31489036 RESULT

• Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.

  PMID: 26615328 RESULT

• Yoo C, Kim KP, Jeong JH, Kim I, Kang MJ, Cheon J, Kang BW, Ryu H, Lee JS, Kim KW, Abou-Alfa GK, Ryoo BY. Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study. Lancet Oncol. 2021 Nov;22(11):1560-1572. doi: 10.1016/S1470-2045(21)00486-1. Epub 2021 Oct 14.

  PMID: 34656226 RESULT

• Chun JW, Woo SM, Lee SH, Choi JH, Park N, Kim JS, Cho IR, Paik WH, Lee WJ, Ryu JK, Kim YT. A real-world analysis of nanoliposomal-irinotecan with 5-fluorouracil and folinic acid as third- or later-line therapy in patients with metastatic pancreatic adenocarcinoma. Ther Adv Med Oncol. 2022 Aug 29;14:17588359221119539. doi: 10.1177/17588359221119539. eCollection 2022.

  PMID: 36062047 RESULT

• Jung JH, Shin DW, Kim J, Lee JC, Hwang JH. Primary Granulocyte Colony-Stimulating Factor Prophylaxis in Metastatic Pancreatic Cancer Patients Treated with FOLFIRINOX as the First-Line Treatment. Cancers (Basel). 2020 Oct 27;12(11):3137. doi: 10.3390/cancers12113137.

  PMID: 33120908 RESULT

• Sasaki M, Ueno H, Mitsunaga S, Ohba A, Hosoi H, Kobayashi S, Ueno M, Terazawa T, Goto M, Inoue D, Namiki S, Sakamoto Y, Kondo S, Morizane C, Ikeda M, Okusaka T. A phase II study of FOLFIRINOX with primary prophylactic pegfilgrastim for chemotherapy-naive Japanese patients with metastatic pancreatic cancer. Int J Clin Oncol. 2021 Nov;26(11):2065-2072. doi: 10.1007/s10147-021-02001-y. Epub 2021 Aug 8.

  PMID: 34368921 RESULT

• Kosaka Y, Rai Y, Masuda N, Takano T, Saeki T, Nakamura S, Shimazaki R, Ito Y, Tokuda Y, Tamura K. Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy. Support Care Cancer. 2015 Apr;23(4):1137-43. doi: 10.1007/s00520-014-2597-1. Epub 2015 Jan 10.

  PMID: 25576433 RESULT

• Sahai V, Catalano PJ, Zalupski MM, Lubner SJ, Menge MR, Nimeiri HS, Munshi HG, Benson AB 3rd, O'Dwyer PJ. Nab-Paclitaxel and Gemcitabine as First-line Treatment of Advanced or Metastatic Cholangiocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1707-1712. doi: 10.1001/jamaoncol.2018.3277.

  PMID: 30178032 RESULT

• Callingham BA. Some aspects of monoamine oxidase pharmacology. Cell Biochem Funct. 1986 Apr;4(2):99-108. doi: 10.1002/cbf.290040204. No abstract available.

  PMID: 3085974 RESULT

• O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.

  PMID: 497341 RESULT

Study Officials

• Sangmyung Woo, M.D

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangmyung Woo, M.D

CONTACT

82-31-920-1733; wsm@ncc.re.kr

Jung Won Chun, M.D

CONTACT

82-31-920-0887; deli4928@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, Senior scientist

Model Details: * Clinical trial phase: Phase 2 * Group allocation: Randomized controlled trial * Research perspective: Prospective study

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: January 16, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)