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

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

NCT ID: NCT06135896

Condition: Unresectable Pancreatic Cancer
Unresectable Bile Duct Carcinoma
Unresectable Biliary Tract Carcinoma

Conditions: Official terms:
Carcinoma
Pancreatic Neoplasms
Carcinoma, Ductal
Neutropenia

Conditions: Keywords:
Unresectable Pancreatic Cancer
Unresectable Bile Duct Carcinoma
Unresectable Biliary Tract Carcinoma

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: - Clinical trial phase: Phase 2 - Group allocation: Randomized controlled trial - Research perspective: Prospective study

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Tripegfilgrastim
Description: Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers
Arm group label: Treatment Group

Other name: Dulastin

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.

Criteria for 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

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: SANGMYUNG WOO, MD

Phone: 82-31-920-1733
Email: wsm@ncc.re.kr

Start date: January 16, 2024

Completion date: June 30, 2026

Lead sponsor:
Agency: National Cancer Center, Korea
Agency class: Other

Collaborator:
Agency: Seoul National University Hospital
Agency class: Other

Source: National Cancer Center, Korea

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06135896
https://academic.oup.com/biomet/article-abstract/64/2/191/384776?redirectedFrom=PDF