Camrelizumab with Chemoradiotherapy for Locally Advanced Biliary Tract Cancer: Preliminary Results from A Phase II Study

Abstract

For locally advanced biliary tract cancer (BTC), capecitabine-based chemoradiotherapy (CRT) is commonly used but has limited benefits. Immunotherapy is potentially effective for BTC and may be synergized with CRT. Followed by gemcitabine and cisplatin (GP) consolidation chemotherapy (CT), we evaluated the safety and efficacy of combined camrelizumab and capecitabine-based CRT for locally advanced BTC. Patients had stage II-III (T4N0M0, T1-4N+M0) BTC (per the 7th [2010] edition of the American Joint Committee on Cancer staging system) were eligible for CRT (capecitabine plus [50-60 Gy] radiotherapy), to be followed by GP CT. Camrelizumab was given concurrently with CRT. Safety was defined as the incidence and severity of adverse events (AEs), while efficacy was defined as overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR). Ten patients completed the planned treatment. None experienced grade ≥3 treatment-related AEs during CRT. Grade ≥3 immune-related AEs occurred in 2 of 10 patients (20%) only during GP CT. The mean OS time was 18.2 months (95% confidence interval [CI] 12.9m-23.5m) while the median OS time was 14.1 months (95% CI 10.1m-18.1m). OS rates were 100%, 59%, 44% at 6 months, 1 year and 2 years, respectively. The ORR was 30% while the DCR was 90%. Two patients (20%) obtained OS over 2 years with partial response (25.9m, 29.1m). Median PFS time was 14.1 months (95% CI 9.3m-18.9m). Camrelizumab in combination with concurrent CRT was well tolerated and did not impair delivery of CRT in patients with locally advanced BTC.