A Phase 2 interventional study of Tripegfilgrastim in Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma and Unresectable Biliary Tract Carcinoma, sponsored by National Cancer Center, Korea. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Supportive care
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.
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Exclusion Criteria:
* 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
* 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.
Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers
Also known as: Dulastin
Primary endpoint
Severe neutropenia incidence
Time frame: through study completion, an average of 1 year
neutropenia incidence
All grades of neutropenia incidence
Time frame: through study completion, an average of 1 year
Febrile neutropenia
Febrile neutropenia incidence
Time frame: through study completion, an average of 1 year
emergency department visits
Frequency of unexpected emergency department visits and length of stay
Time frame: through study completion, an average of 1 year
Overall survival
Overall survival
Time frame: through study completion, an average of 1 year
Progression-free survival
Progression-free survival
Time frame: through study completion, an average of 1 year
biomarkers
Predictive biomarkers for treatment response analysis
Time frame: through study completion, an average of 1 year
Plan to share: No
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National Cancer Center, Korea