Clinical trial NCT06135896: Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Official title: An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Unresectable Pancreatic Cancer
Unresectable Bile Duct Carcinoma
Unresectable Biliary Tract Carcinoma
Keywords: Unresectable Pancreatic Cancer
Unresectable Bile Duct Carcinoma
Unresectable Biliary Tract Carcinoma
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Hospital
First posted: 2023-11-18
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Clinical trial phase: Phase 2
* Group allocation: Randomized controlled trial
* Research perspective: Prospective study
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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

Primary outcomes:
measure: Primary endpoint
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: neutropenia incidence
timeFrame: through study completion, an average of 1 year
measure: Febrile neutropenia
timeFrame: through study completion, an average of 1 year
measure: emergency department visits
timeFrame: through study completion, an average of 1 year
measure: Overall survival
timeFrame: through study completion, an average of 1 year
measure: Progression-free survival
timeFrame: through study completion, an average of 1 year
measure: biomarkers
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Sangmyung Woo, M.D
role: PRINCIPAL_INVESTIGATOR
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