The efficacy and safety of short-course radiotherapy followed by sequential chemotherapy and Cadonilimab for locally advanced rectal cancer: a protocol of a phase II study

作者：Tongzhen Xu, Lingling Feng, Wenjue Zhang, Haoyue Li, Huiying Ma, Muyasha Abulimiti, Yutong Tan, Fei‐Yan Deng, Wenting Huang, Shuangmei Zou, Wenyan Kang, Liming Jiang, Ying Wang, Hu Chen, Yinggang Chen, Haitao Zhou, Yuan Tang, Jing Jin · 发表于：BMC Cancer · 年份：2024 · DOI：10.1186/s12885-024-12254-1 · 被引用次数：5 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Cancer Immunotherapy and Biomarkers

BACKGROUND: For patients with locally advanced rectal cancer (LARC), total neoadjuvant therapy (TNT), namely, intensifying preoperative treatment through the integration of radiotherapy and systemic chemotherapy before surgery, was commonly recommended as the standard treatment. However, the risk of distant metastasis at 3 years remained higher than 20%, and the complete response (CR) rate was less than 30%. Several clinical trials had suggested a higher complete response rate when combining single-agent immunotherapy with short-course radiotherapy (SCRT). The CheckMate 142 study had shown encouraging outcomes of dual immunotherapy and seemingly comparable toxicity for CRC compared with single-agent immunotherapy in historical results. Therefore, dual immunotherapy might be more feasible in conjunction with the TNT paradigm of SCRT. We performed a phase II study to investigate whether the addition of a dual immune checkpoint inhibitor bispecific antibody, Cadonilimab, to SCRT combined with chemotherapy might further increase the clinical benefit and prognosis for LARC patients. METHODS: This single-arm, multicenter, prospective, phase II study included patients with pathologically confirmed cT3-T4N0 or cT2-4N + rectal adenocarcinoma with an ECOG performance score of 0 or 1. Bispecific antibody immunotherapy was added to SCRT combined with chemotherapy. Patients enrolled would be treated with SCRT (25 Gy in five fractions over 1 week) for the pelvic cavity, followed by 4 cycle...