Shandong Cancer Hospital and Institute Jinan, Shandong
Q. Guo1,2, M. Li1, X. Zhang3, J. Liu1, F. Shi3, K. Zhu3, S. Jiang3, X. Dou1, X. Xu1, R. Feng3, and J. Yue1,4; 1Shandong Cancer Hospital and Institute, Jinan, China, 2Shandong University Cancer Center, Jinan, China, 3Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China, 4Department of Radiation Oncology, Shandong University Cancer Center, Jinan, China
Purpose/Objective(s): No standard treatment exists for locally advanced biliary tract cancer (LABTC). Capecitabine-based concurrent chemoradiotherapy (CRT) is commonly used but has limited survival benefit. This study (ChiCTR2000031786) evaluated the safety and efficacy of adding immunotherapy to CRT for LABTC. Materials/
Methods: Patients had stage II-III BTC (T4N0M0; T1-4N1M0) (per the 8th edition of the American Joint Committee on Cancer staging system) and were eligible for chemoradioimmunotherapy (CRIT). Camrelizumab as immunotherapy was given in CRIT followed by chemoimmunotherapy (CIT). Safety was defined by the incidence and severity of treatment-related adverse events (TRAEs); efficacy was assessed by objective response rate (ORR), progression-free survival (PFS) rate, and overall survival (OS) rate. Results: Twenty patients enrolled in this clinical trial. No patient experienced any severe (grade 3 and higher) AE in kidney function, liver function, blood coagulation or diarrhea. Haematological toxicity, particularly lymphopenia (60%, 95%CI [38.5%-81.5%]) was the most common adverse events in this clinical trial. Six out of 20 patients (30.0% [9.9%–50.1%]) achieved an objective response after protocol treatment. The 1-year, 1.5-year OS and PFS rates were as follows: 55.0% [30.0%-74.0%], 45.0% [23.0%-69.0%], 40.0% [19.0%-64.0%], and 30.0% [12.0%-54.0%], respectively (n=20). Among the patients who complete CRIT and CIT (n=15), the 1-year, 1.5-year OS and PFS rates were 60.0% [31.0%-73.0%], 46.6% [21.0%-73.0%], 40.0% [8.0%-55.0%], and 33.6% [16.0%-68.0%], respectively. Conclusion: CRIT followed by CIT was tolerable and feasible for patients with LABTC. Haematological toxicity, particularly lymphopenia deserved more attention on safety.
