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

Unresectable Pancreatic Cancer Clinical Trial

— Dulastin  

Official title:

An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06135896
• Other study ID #: NCC2023-0235
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 10, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2023
• Source: National Cancer Center, Korea
• Contact: Sangmyung Woo, M.D
• Phone: 82-31-920-1733
• Email: wsm[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Pancreatic cancer and Bile duct cancer are the 8th and 9th leading causes of all cancer in Korea, have 5-year survival rates of approximately 20%, and unresectable cancers show a poor prognosis of approximately 5%. The first-line treatment recommended for unresectable pancreaticobiliary cancer is chemotherapy. FOLFIRINOX or gemcitabine/nab-paclitaxel combination therapy is recommended for pancreatic cancer, and gemcitabine/cisplatin combination therapy is recommended for bile duct cancer. Recently, anticancer therapy advances have led to an increase in survival for pancreaticobiliary cancer patients, and more than half of patients receive secondary chemotherapy due to disease progression after first-line treatment. Recently, with the introduction of nanoliposomal irinotecan (nal-IRI) and the clinical outcomes of Phase 3 NAPOL-1 trial and the Phase 2b NIFTY trial, nal-IRI/5-FU/LV combination therapy is being used as second-line chemotherapy following gemcitabine treatment. Granulocyte colony-stimulating factors (G-CSFs) (filgrastim, pegfilgrastim, and tripegfilgrastim) can be used for neutropenia prevention and treatment. In particular, pegylated G-CSF can reduce patient discomfort due to its long retention time. In a retrospective study analyzing the use of G-CSF for primary neutropenia prevention in Korea, pancreatic cancer patients who received FOLFIRINOX treatment that exhibited neutropenia and FN were significantly reduced from 55.6% to 31.6% (P = 0.003) and from 18.5% to 1.8% (P = 0.002), respectively. Similarly, in a retrospective study in Japan, preventive pegylated G-CSF treatment reduced the incidence of FN from 23% to 0%, and in a double-blinded, randomized, phase 3 breast cancer clinical trial, pegylated G-CSF treatment significantly reduced the incidence of FN from 68.8% to 1.2%. In a retrospective study of non-small cell lung cancer, another solid cancer, the incidence of FN in the preventive pegylated G-CSF treatment group was 0%, compared to an incidence of 50% in the control group.

However, no studies have evaluated the efficacy of G-CSF in pancreaticobiliary cancer patients receiving nal-IRI/5-FU/LV combination therapy yet. Hence, our objective was to report the effects of pegylated G-CSF on preventing severe neutropenia in patients receiving nal-IRI/5-FU/LV combination chemotherapy for unresectable pancreaticobiliary cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 experienced severe neutropenia during chemotherapy

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ductal
• Neutropenia
• Pancreatic Neoplasms
• Unresectable Pancreatic Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Seoul National University Hospital

References & Publications (13)

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. — View Citation

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. Oncol — View Citation

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 adenoc — View Citation

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/cance — View Citation

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 — View Citation

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 d — View Citation

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

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 — View Citation

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 — View Citation

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 Cl — View Citation

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. Nanoli — View Citation

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 adeno — View Citation

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 gemc — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint	Severe neutropenia incidence	through study completion, an average of 1 year
Secondary	neutropenia incidence	All grades of neutropenia incidence	through study completion, an average of 1 year
Secondary	Febrile neutropenia	Febrile neutropenia incidence	through study completion, an average of 1 year
Secondary	emergency department visits	Frequency of unexpected emergency department visits and length of stay	through study completion, an average of 1 year
Secondary	Overall survival	Overall survival	through study completion, an average of 1 year
Secondary	Progression-free survival	Progression-free survival	through study completion, an average of 1 year
Secondary	biomarkers	Predictive biomarkers for treatment response analysis	through study completion, an average of 1 year

External Links

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