Unresectable Pancreatic CancerPhase 2DulastinNCT06135896
Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
A Phase 2 study testing Tripegfilgrastim in people with Unresectable Pancreatic Cancer and Unresectable Bile Duct Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract Carcinoma
- What is being tested?
- Tripegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jan 2024to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
Goyang-si, Gyeonggi-do, 10408
SANGMYUNG WOO, MD, 82-31-920-1733, wsm@ncc.re.kr
About this study
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 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
Read the 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.
- Conditions
- Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract Carcinoma
- Being tested
- Tripegfilgrastim
- Keywords
- Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TripegfilgrastimDrug
Also called Dulastin
Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | * 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 Receives: Drug: Tripegfilgrastim |
| Control Group | No intervention | * 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Severe neutropenia incidence
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
neutropenia incidence
All grades of neutropenia incidence
Measured: through study completion, an average of 1 year
Febrile neutropenia
Febrile neutropenia incidence
Measured: through study completion, an average of 1 year
emergency department visits
Frequency of unexpected emergency department visits and length of stay
Measured: through study completion, an average of 1 year
Overall survival
Overall survival
Measured: through study completion, an average of 1 year
Progression-free survival
Progression-free survival
Measured: through study completion, an average of 1 year
biomarkers
Predictive biomarkers for treatment response analysis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start16 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Unresectable Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Clinical trial phase: Phase 2 * Group allocation: Randomized controlled trial * Research perspective: Prospective study
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Seoul National University Hospital
- Responsible party
- Principal investigator, Sang Myung Woo, National Cancer Center, Korea
- Investigators
- Sangmyung Woo, M.D, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135896
- Sponsor's protocol ID
- NCC2023-0235
- Acronym
- Dulastin
- Status last verified
- Jun 2025
- First submitted
- 7 Nov 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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/s41598-022-13605-3.
PubMed 35715440Canton 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. Oncologist. 2022 Jul 5;27(7):e571-e579. doi: 10.1093/oncolo/oyac055.
PubMed 35289915Shroff 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 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270.
PubMed 30998813Yoo 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 adenocarcinoma: a study by the Korean Cancer Study Group. Ther Adv Med Oncol. 2019 Aug 23;11:1758835919871126. doi: 10.1177/1758835919871126. eCollection 2019.
PubMed 31489036Wang-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. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.
PubMed 26615328Yoo 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 gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study. Lancet Oncol. 2021 Nov;22(11):1560-1572. doi: 10.1016/S1470-2045(21)00486-1. Epub 2021 Oct 14.
PubMed 34656226Chun 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 adenocarcinoma. Ther Adv Med Oncol. 2022 Aug 29;14:17588359221119539. doi: 10.1177/17588359221119539. eCollection 2022.
PubMed 36062047Jung 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/cancers12113137.
PubMed 33120908Sasaki 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 Japanese patients with metastatic pancreatic cancer. Int J Clin Oncol. 2021 Nov;26(11):2065-2072. doi: 10.1007/s10147-021-02001-y. Epub 2021 Aug 8.
PubMed 34368921Kosaka 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 docetaxel/cyclophosphamide chemotherapy. Support Care Cancer. 2015 Apr;23(4):1137-43. doi: 10.1007/s00520-014-2597-1. Epub 2015 Jan 10.
PubMed 25576433Sahai 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;4(12):1707-1712. doi: 10.1001/jamaoncol.2018.3277.
PubMed 30178032Callingham BA. Some aspects of monoamine oxidase pharmacology. Cell Biochem Funct. 1986 Apr;4(2):99-108. doi: 10.1002/cbf.290040204. No abstract available.
PubMed 3085974O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
PubMed 497341
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
- ClinicalTrials.gov ID
- NCT06135896
- Acronym / sponsor ID
- Dulastin / NCC2023-0235
- Conditions
- Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract Carcinoma
- Keywords
- Unresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul National University Hospital
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Clinical trial phase: Phase 2 * Group allocation: Randomized controlled trial * Research perspective: Prospective study
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Tripegfilgrastim* 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 |
| Control Group | No intervention | –* 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TripegfilgrastimAlso: DulastinTripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers | Drug | Treatment Group |
Primary outcome
Primary endpoint
Time frame: through study completion, an average of 1 year
Severe neutropenia incidence
6 secondary outcomes
neutropenia incidence
Time frame: through study completion, an average of 1 year
Febrile neutropenia
Time frame: through study completion, an average of 1 year
emergency department visits
Time frame: through study completion, an average of 1 year
Overall survival
Time frame: through study completion, an average of 1 year
Progression-free survival
Time frame: through study completion, an average of 1 year
biomarkers
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Results publication: PubMed 35715440Kang 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/s41598-022-13605-3.
- Results publication: PubMed 35289915Canton 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. Oncologist. 2022 Jul 5;27(7):e571-e579. doi: 10.1093/oncolo/oyac055.
- Results publication: PubMed 30998813Shroff 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 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270.
- Results publication: PubMed 31489036Yoo 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 adenocarcinoma: a study by the Korean Cancer Study Group. Ther Adv Med Oncol. 2019 Aug 23;11:1758835919871126. doi: 10.1177/1758835919871126. eCollection 2019.
- Results publication: PubMed 26615328Wang-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. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.
- Results publication: PubMed 34656226Yoo 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 gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study. Lancet Oncol. 2021 Nov;22(11):1560-1572. doi: 10.1016/S1470-2045(21)00486-1. Epub 2021 Oct 14.
- Results publication: PubMed 36062047Chun 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 adenocarcinoma. Ther Adv Med Oncol. 2022 Aug 29;14:17588359221119539. doi: 10.1177/17588359221119539. eCollection 2022.
- Results publication: PubMed 33120908Jung 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/cancers12113137.
- Results publication: PubMed 34368921Sasaki 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 Japanese patients with metastatic pancreatic cancer. Int J Clin Oncol. 2021 Nov;26(11):2065-2072. doi: 10.1007/s10147-021-02001-y. Epub 2021 Aug 8.
- Results publication: PubMed 25576433Kosaka 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 docetaxel/cyclophosphamide chemotherapy. Support Care Cancer. 2015 Apr;23(4):1137-43. doi: 10.1007/s00520-014-2597-1. Epub 2015 Jan 10.
- Results publication: PubMed 30178032Sahai 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;4(12):1707-1712. doi: 10.1001/jamaoncol.2018.3277.
- Results publication: PubMed 3085974Callingham BA. Some aspects of monoamine oxidase pharmacology. Cell Biochem Funct. 1986 Apr;4(2):99-108. doi: 10.1002/cbf.290040204. No abstract available.
- Individual participant dataSharing planned: No
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A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sangmyung Woo, M.D principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tripegfilgrastim in people with Unresectable Pancreatic Cancer and Unresectable Bile Duct Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sangmyung Woo, M.D (82-31-920-1733, wsm@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135896, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.