Published in
Karger Publishers, Liver Cancer, 5(11), p. 451-459, 2022
DOI: 10.1159/000525489
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Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial
,
Chanisa Chotipanich,
Su Pin Choo ,
Su Wen Kwang,
Frankie Mo ,
Akeanong Worakitsitisatorn ,
David Tai,
Raghav Sundar ,
David Chee Eng Ng,
Kelvin Siu Hoong Loke,
Leung Li ,
Kelvin Kwok Chai Ng ,
Yong Wei Peng ,
Simon Chun-Ho Yu
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Abstract
<b><i>Introduction:</i></b> This investigator-initiated clinical trial aims to study the efficacy and safety of administering selective internal radiation therapy with resin yttrium-90 microspheres (SIRT) followed by standard chemotherapy in unresectable intrahepatic cholangiocarcinoma (ICC). <b><i>Methods:</i></b> A phase 2 single-arm multicenter study was conducted in patients with unresectable ICC (NCT02167711). SIRT was administered at dose of 120 Gy targeted at tumor followed by commencement of gemcitabine 1,000 mg/m<sup>2</sup> and cisplatin 25 mg/m<sup>2</sup> on days one and eight of a 21-day cycle. The primary endpoint was overall survival (OS), and the secondary endpoints include progression-free survival (PFS), response rate according to Response Evaluation Criteria in solid tumors 1.1, toxicity, and time from SIRT to commencement of chemotherapy. <b><i>Results:</i></b> Total 31 patients were screened and twenty-four were recruited. All patients completed SIRT and 16 of them underwent subsequent chemotherapy. The median cycle of chemotherapy was 5 (range: 1–8). The median OS was 13.6 months (95% CI: 5.4–21.6) for the intent-to-treat population. Among 16 patients undergoing chemotherapy, the median OS was 21.6 months (95% CI: 7.3–25.2) and the median PFS was 9 months (95% CI: 3.2–13.1). The response rate was 25% (95% CI: 3.8–46.2%), and the disease control rate was 75% (95% CI: 53.8–96.2%). No new safety signal was observed, with fewer than 10% of patients suffering from grade 3 or higher treatment-related adverse events. The median time from SIRT to chemotherapy was 29 (range: 7–42) days. Eight patients could not receive chemotherapy due to rapid progressive disease (<i>n</i> = 4), underlying treatment unrelated comorbidities (<i>n</i> = 2), and withdrawal of consent due to personal reasons (<i>n</i> = 2). <b><i>Conclusions:</i></b> Treatment of SIRT followed by standard gemcitabine and cisplatin chemotherapy is feasible and effective for unresectable ICC. Further studies are required to study the optimal sequence of SIRT and chemotherapy.