Abstract 1530
Background
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
NCT03524508.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Shire and Servier.
Disclosure
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.
Resources from the same session
5345 - Short-term Clinical Outcomes of Robotic-Assisted Total Mesorectal Excision in Rectal Cancer after concurrent chemoradiotherapy
Presenter: Pojung Chen
Session: Poster Display session 2
Resources:
Abstract
5489 - Local immune status in cancer cell nests can be a predictor of survival for rectal cancer with neoadjuvant radiotherapy
Presenter: xijin lin
Session: Poster Display session 2
Resources:
Abstract
1653 - Impact of concomitant medications on disease free survival (DFS) and overall survival (OS) in patients from the PETACC8 study.
Presenter: Clémence Brun
Session: Poster Display session 2
Resources:
Abstract
5206 - Updated results of NORDIC 8, a randomised trial of cetuximab every 2 weeks with FOLFIRI or cetuximab with alternating FOLFIRI/FOLFOX in patients with RAS and BRAF wild type metastatic colorectal cancer.
Presenter: Per Pfeiffer
Session: Poster Display session 2
Resources:
Abstract
2992 - Clinical impact of mucinous and poorly differentiated tumors on the outcome of patients with stage II colon cancer: a TOSCA subgroup analysis
Presenter: Gerardo Rosati
Session: Poster Display session 2
Resources:
Abstract
4753 - Exercise improved adjuvant treatment completion rates and treatment-related toxicities in colorectal cancer: A prospective pilot study
Presenter: Hong Jun Kim
Session: Poster Display session 2
Resources:
Abstract
2735 - Bevacizumab plus Oxaliplatin-Based Chemotherapy as Adjuvant Treatment for Colon Cancer (CC): Updated analysis of stage II disease from the AVANT Phase III Randomized trial by the GERCOR Group
Presenter: Aimery De Gramont
Session: Poster Display session 2
Resources:
Abstract
1843 - Multicenter Validation of the Postoperative Carcinoembryonic Antigen Combined Prognostic Model for Stage Ⅲ Colon Cancer
Presenter: Ji Zhu
Session: Poster Display session 2
Resources:
Abstract
2554 - Impact of the IDEA study on clinical practice for stage III colon cancer patients: a French GERCOR - FFCD - GI UNICANCER national survey.
Presenter: Kaissa Ouali
Session: Poster Display session 2
Resources:
Abstract
3285 - Sex hormones and sperm parameters after adjuvant oxaliplatin-based treatment for colorectal cancer
Presenter: Philip Falk
Session: Poster Display session 2
Resources:
Abstract