RT Journal Article SR Electronic T1 Multicenter Phase II Clinical Trial of Genexol-PM® with Gemcitabine in Advanced Biliary Tract Cancer JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 1467 OP 1473 VO 37 IS 3 A1 JIN YOUNG KIM A1 YOUNG ROK DO A1 HONG SUK SONG A1 YOON YOUNG CHO A1 HUN MO RYOO A1 SUNG HWA BAE A1 JONG GWANG KIM A1 YEE SOO CHAE A1 BYUNG WOOG KANG A1 JIN HO BAEK A1 MIN KYOUNG KIM A1 KYUNG HEE LEE A1 KEONUK PARK YR 2017 UL http://ar.iiarjournals.org/content/37/3/1467.abstract AB This multicenter phase II clinical trial was designed to evaluate the efficacy and safety of weekly Genexol-PM® and gemcitabine combination chemotherapy in patients with unresectable or metastatic biliary tract cancer. Patients and Methods: Patients received 100 mg/m2 Genexol-PM® and 1,000 mg/m2 gemcitabine intravenously on days 1 and 8 every 21 days. Results: Out of 39 patients, there were 10 partial responses (25.6%) and 18 with stable diseases (46.2%) were confirmed with median response duration 4.1 months. The median progression-free survival was 5.9±1.6 months and overall survival 11.9±1.4 months. The median number of cycles administered was 4.0 (range=1-10). Grade 3 or more neutropenia occurred in 12 patients (26.7%). The most common grade 3/4 non-hematological toxicities were febrile neutropenia (13.4%) and elevation of liver enzymes (6.7%). Conclusion: Weekly Genexol-PM® combined with gemcitabine demonstrated sufficient antitumor activity to warrant further development when used as first-line chemotherapy for advanced biliary tract cancer.