Dulastin: Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Study Details
Study Description
Brief Summary
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Clinical trial phase: Phase 2
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Intervention model: Control group
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Group allocation: Randomized controlled trial
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Research perspective: Prospective study
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Participating centers: Multicenter study
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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.
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The intervention period is from the date of IRB approval to December 31st, 2025
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The follow-up duration is one year, and the statistical analysis duration is six months
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The total research period is from the date of IRB approval to June 30th, 2026
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: Tripegfilgrastim
Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers
Other Names:
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| 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. |
Outcome Measures
Primary Outcome Measures
- Primary endpoint [through study completion, an average of 1 year]
Severe neutropenia incidence
Secondary Outcome Measures
- neutropenia incidence [through study completion, an average of 1 year]
All grades of neutropenia incidence
- Febrile neutropenia [through study completion, an average of 1 year]
Febrile neutropenia incidence
- emergency department visits [through study completion, an average of 1 year]
Frequency of unexpected emergency department visits and length of stay
- Overall survival [through study completion, an average of 1 year]
Overall survival
- Progression-free survival [through study completion, an average of 1 year]
Progression-free survival
- biomarkers [through study completion, an average of 1 year]
Predictive biomarkers for treatment response analysis
Eligibility Criteria
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:
- Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National Cancer Center, Korea
- Seoul National University Hospital
Investigators
- Principal Investigator: Sangmyung Woo, M.D, National Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- NCC2023-0235