[摘 要] 目的：评估放疗作为原位疫苗的联合治疗模式在晚期软组织肉瘤（STS）患者中的有效性和安全性。方法：回顾性分 析2020年12月至2024年9月期间在南京大学医学院附属鼓楼医院肿瘤中心接受联合治疗模式的12例晚期STS患者的临床资 料。12例患者均接受了联合治疗。放疗主要以大分割为主。靶向治疗：安罗替尼10例、阿帕替尼2例。免疫治疗以PD-1抗体为 主。主要研究终点为疾病控制率（DCR），次要研究终点为客观有效率（ORR）及安全性。结果：接受联合治疗的12例STS患者 中有0例CR，4例PR，7例SD，1例PD。ORR为33%，DCR为91.7%，其中靶病灶的DCR为100%。12例患者中，9例出现Ⅰ~Ⅱ级 不良反应。最常发生的血液学不良反应是贫血（6例）、肝功能检查结果异常（3例）。最常发生的非血液学不良反应是尿蛋白（5 例）、高血压（4例）、甲状腺功能异常（3例）、厌食（3例）、恶心呕吐（2例）；仅2例发生Ⅲ级血液毒性，有1例发生Ⅲ级气胸。结论： 放疗作为原位疫苗的联合治疗模式在晚期STS患者中展现出较高的DCR，且未出现严重不良反应。该联合治疗模式具有良好的 有效性与安全性。

[Abstract] Objective: To evaluate the efficacy and safety of radiotherapy as a combined mode with in-situ vaccine for patients with advanced soft tissue sarcoma (STS). Methods: The clinical data of 12 patients with advanced STS who received combination therapy mode at the Cancer Center of Gulou Hospital Affiliated to the School of Medicine of Nanjing University between December 2020 and September 2024 were retrospectively analyzed. All 12 patients received combined therapy. The main radiotherapeutic approach was hypofractionated radiotherapy. The targeted therapy mainly involved Anlotinib (in 10 cases) or Apatinib (in 2 cases). Immunotherapy mainly involved PD-1 antibodies. The primary endpoint was disease control rate (DCR), and the secondary endpoints were objective response rate (ORR) and safety. Results: Among the 12 STS patients who received combined treatment, 0 cases achieved CR, 4 cases achieved PR; 7 cases had SD, and 1 case had PD. The ORR was 33%, and the DCR was 91.7%, among which the DCR of the target lesions was 100%. Among the 12 patients, 9 patients experienced grade Ⅰ to grade Ⅱ adverse reactions. The most frequently occurring hematological adverse reactions were anemia (6 cases) and abnormal results of liver function tests (3 cases). The most frequently occurring non-hematological adverse reactions were proteinuria (5 cases), hypertension (4 cases), abnormal thyroid function (3 cases), anorexia (3 cases), and nausea and vomiting (2 cases). Only 2 cases had grade Ⅲ hematological toxicity, and 1 case had grade Ⅲ pneumothorax. Conclusion: Radiotherapy as a combined therapy mode with in situ vaccine can achieve a higher DCR in advanced soft tissue sarcomas without serious adverse reactions. This combined treatment modality demonstrates good efficacy and safety.

国家自然科学基金（No. 82272852）；江苏省杰出青年学者基金（No. BK20240017）；南京鼓楼医院临床研究专项 资金培育项目（No. 2022-LCYJ-PY-21）；南京鼓楼医院临床研究专项资金（No. 2022-LCYJ-MS-09）