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
3159 - Anlotinib for advanced hepatocellular carcinoma: interim results from the phase II ALTER0802 study
Presenter: AiPing Zhou
Session: Poster Display session 2
Resources:
Abstract
3191 - The efficacy and safety of lenvatinib in patients who did not meet the inclusion criteria of the phase 3 trial (REFLECT trial) and those with BCLC Stage B hepatocellular carcinoma - A nationwide multicenter study in Japan-
Presenter: Azusa Sakamoto
Session: Poster Display session 2
Resources:
Abstract
1529 - Prognostic and predictive value of baseline alpha-fetoprotein (AFP) in patients with advanced hepatocellular carcinoma (HCC) treated with ramucirumab from two phase 3 studies (REACH, REACH-2)
Presenter: Andrew Zhu
Session: Poster Display session 2
Resources:
Abstract
2767 - Effect of second-line cabozantinib on health states for patients with advanced hepatocellular carcinoma (aHCC) after sorafenib: QTWiST analysis from the CELESTIAL study
Presenter: Nicholas Freemantle
Session: Poster Display session 2
Resources:
Abstract
2150 - Alpha-fetoprotein (AFP) response in patients with unresectable hepatocellular carcinoma (HCC) in the phase 3 RESORCE trial
Presenter: Jordi Bruix
Session: Poster Display session 2
Resources:
Abstract
3437 - Phase I/II trial of NBTXR3 activated by SBRT in patients with hepatocellular carcinoma or liver metastasis
Presenter: Marc Pracht
Session: Poster Display session 2
Resources:
Abstract
1758 - Efficacy and safety of ramucirumab (RAM) for advanced hepatocellular carcinoma (HCC) with elevated alpha-fetoprotein (AFP) following first-line sorafenib across age subgroups in two global phase 3 trials (REACH and REACH-2)
Presenter: Masatoshi Kudo
Session: Poster Display session 2
Resources:
Abstract
1192 - Ramucirumab in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha fetoprotein (AFP): An exposure–response analysis
Presenter: Josep Llovet
Session: Poster Display session 2
Resources:
Abstract
1600 - Outcomes of Hepatocellular Carcinoma (HCC) Patients Treated with Nivolumab: The Mount Sinai Hospital Experience.
Presenter: Sirish Dharmapuri
Session: Poster Display session 2
Resources:
Abstract
2364 - Pembrolizumab vs Chemotherapy in Patients With Advanced/Metastatic Adenocarcinoma (AC) or Squamous Cell Carcinoma (SCC) of the Esophagus as Second-Line Therapy: Analysis of the Chinese Subgroup in KEYNOTE-181
Presenter: Jia Chen
Session: Poster Display session 2
Resources:
Abstract