醫學研究 學術文章 SIRT-Y90 followed by gemcitabine plus cisplatin for Intra-hepatic cholangiocarcinoma: a phase II study. Chan SL, Tai D, Li L, Yu SCH, Ng D, Choo SP. Ann Oncol. 2015; 26 (Supplement 7): vii106-vii151. doi:10.1093/annonc/mdv472.72.肝癌 Liver cancer
SIRT-Y90 followed by gemcitabine plus cisplatin for Intra-hepatic cholangiocarcinoma: a phase II study
Chan SL, Tai D, Li L, Yu SCH, Ng D, Choo SP. Ann Oncol. 2015; 26 (Supplement 7): vii106-vii151. doi:10.1093/annonc/mdv472.72.
Abstract
Background: The standard of care for unresectable cholangiocarcinoma is palliative gemcitabine and cisplatin chemotherapy. Several series have shown that SIRT-Y90 is effective in inoperable localized intrahepatic cholangiocarcinoma with up to 36% partial responses. Our hypothesis is that targeting cholangiocarcinomas with SIRT-Y90 and gemcitabine/cisplatin chemotherapy will increase both local control and survival outcomes. This phase II clinical trial aims to determine the efficacy of the sequential combination of SIR-spheres and standard gemcitabine-cisplatin (Gem-Cis) chemotherapy regimen.
Methods: This is a single arm, phase 2 trial that will recruit 24 patients. Eligible patients include those with unresectable, histologically-proven intrahepatic cholangiocarcinoma that is treatment-naïve, ECOG performance score of 0-1 and adequate organ function. Patients with extra-hepatic metastases will be excluded except those with regional lymph node metastases. If eligible, SIRT-Y90 ( at least 120Gy) will be given first. Twenty-eight days later, gemcitabine 1g/m2 and cisplatin 25mg/m2 will be given on Day 1 and Day 8 every 21 days, for up to 8 cycles. The primary endpoint is the overall survival and secondary endpoints are progression-free survival, radiological response rate, disease control rate, duration between timing of chemotherapy and SIRT-Y90, and toxicity rates. It is hypothesized that the addition of SIRT-Y90 could improve the median OS to 14 months. In order to detect the 4 months of difference with one-sided alpha level 0.05 and 80% power, 24 patients will be recruited. A total follow-up for at least 12 months is required for this study. The trial was activated in September 2014 and is conducted at 2 sites. Clinical trial number: NCT02167711
Citation:
Chan SL, Tai D, Li L, Yu SCH, Ng D, Choo SP. SIRT-Y90 followed by gemcitabine plus cisplatin for Intra-hepatic cholangiocarcinoma: a phase II study. Ann Oncol. 2015; 26 (Supplement 7): vii106-vii151. doi:10.1093/annonc/mdv472.72.