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Poster Display session 2

1530 - Multicenter randomized phase II trial of 5-Fluorouracil/leucovorin (5-FU/LV) with or without liposomal irinotecan (nal-IRI) in metastatic biliary tract cancer (BTC) as second-line therapy after progression on gemcitabine plus cisplatin (GemCis): NIFTY trial


29 Sep 2019


Poster Display session 2


Tumour Site

Hepatobiliary Cancers


Changhoon Yoo


Annals of Oncology (2019) 30 (suppl_5): v253-v324. 10.1093/annonc/mdz247


C. Yoo1, J.H. Jeong1, K. Kim1, J. Cheon2, I. Kim3, M. Kang3, H. Ryu4, B.W. Kang5, B. Ryoo1

Author affiliations

  • 1 Dept. Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-931 - Seoul/KR
  • 2 Hematology And Oncology, Ulsan University Hospital, 05505 - Ulsan/KR
  • 3 Internal Medicine, Inje University College of Medicine, 05505 - Busan/KR
  • 4 Internal Medicine, Chungnam National University Hospital, 05505 - Daejeon/KR
  • 5 Kyungpook National University, Kyungpook National University, 05505 - Daegu/KR


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Abstract 1530


Patients with BTC have dismal prognosis with 5-year survival of less than 10%. GemCis is the globally established first-line therapy based on the phase III ABC-02 trial. However, there is no standard second-line therapy after failure of 1st line GemCis, although 5-FU-based therapy has been widely used. Nal-IRI (Onivyde®) comprises irinotecan sucrosofate salt encapsulated in pegylated liposomes that protect the drug from premature conversion in the liver. This randomized phase 2 trial is designed to compare the clinical outcomes between nal-IRI plus 5-FU/LV with 5-FU/LV alone as 2nd line therapy in patients with BTC who progressed on 1st line Gem/Cis.

Trial design

NIFTY trial is a multicenter, open-label, randomized, phase II trial and 5 referral cancer centers in Korea participated in this study. Histologically documented biliary tract cancer (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), documented progression on 1st line Gem/Cis, and at least one measurable lesion are key inclusion criteria. Eligible patients are randomized with 1:1 ratio to experimental arm (80 mg/m2 irinotecan hydrochloride trihydrate salt equivalent to 70 mg/m2 irinotecan free base over 90 minutes, followed by 400 mg/m2 LV over 30 min, and then 2400 mg/m2 5-FU over 46 h, every 2 weeks) and control arm (400 mg/m2 LV over 30 min, and then 2400 mg/m2 5-FU over 46 h, every 2 week). Response evaluation is graded by RECIST v1.1 and conducted every 6 weeks. Primary endpoint is progression-free survival and secondary endpoints are overall survival, response rates, quality of life assessed by EORTC QLQ-C30 and safety profile. We hypothesized that the addition of nal-IRI to 5-FU/LV would enhance the PFS to median 3.3 months (P1) from median 2.0 (P0) with 5-FU/LV alone. With alpha of 0.05, power of 80%, and drop-out rates of 10%, a total of 174 patients (87 patients per each arm) are needed based on this hypothesis. As of March 2019, a total of 89 patients (51% of the target number) are enrolled.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

The authors.


Shire and Servier.


C. Yoo: Research grant / Funding (self): Shire; Advisory / Consultancy, Research grant / Funding (self): Servier; Honoraria (self): Ipsen. All other authors have declared no conflicts of interest.

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