Efficacy and Safety of PD-1 Inhibitor SHR-1210 With Chemoradiotherapy in Locally Advanced Cholangiocarcinoma

• DOI: 10.1016/j.ijrobp.2021.07.458
• Publication Date: 2021-10-25T14:40:54Z
• Authors: J. Yue; R. Feng
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

Purpose/Objective(s) To preliminarily evaluate the efficacy and safety of adding PD-1 inhibitor SHR-1210 to chemoradiotherapy in patients with locally advanced cholangiocarcinoma. Materials/Methods Patients with confirmed diagnosis of locally advanced cholangiocarcinoma based on histopathological and radiological features were included in the study. Patients received a total dose of 50–60 Gy in 25–30 fractions with concurrent capecitabine (825 mg/m2, po, bid) and SHR-1210 (200mg, iv, q2w) on days of radiation. Further consolidation chemotherapy was initiated after completion of radiotherapy and included 4 cycles of gemcitabine (1000 mg/m2, iv, Day 1, 8) and cisplatin (75 mg/m2, iv, with total volume divided at Day 1-3) in a 21-day cycle with SHR-1210 (200mg, iv, q3w). All patients received study treatment until SHR-1210 was administered for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent. Results From November 2019 to October 2020, 10 patients were enrolled in the study (6 male [60%], median age, 56 [range, 50-66] years, 4 IIIb stage, 6 IIIc stage). All patients completed radiotherapy. Six patients (60%) experienced myelosuppression, including two with grade 4 advert events (AEs), one stopped chemotherapy and one stopped study treatment. Four patients (40%) developed grade 2 gastrointestinal tract reactions, and the incidence of grade ≤ 3 reactive cutaneous capillary endothelial proliferation (RCCEP) was 100%. All patients had an apparent decrease in the tumor markers CEA and CA-199 levels with symptoms significantly relieved as response to treatment. Among 10 patients treated, 0 (0%) exhibited complete response (CR), 5 (50%) exhibited partial response (PR), 4 (40%) exhibited stable disease (SD) and 1 (10%) exhibited disease progression (PD). The 6-month progression-free survival rate (PFS) was 90%. Conclusion These findings suggest that combined treatment with PD-1inhibitors and chemoradiotherapy for locally advanced cholangiocarcinoma is tolerable and effective, which provides a new strategy for the treatment of locally advanced cholangiocarcinoma.