目的：评估信迪利单抗联合贝伐珠单抗在真实世界晚期实体肿瘤患者治疗中的安全性。方法：本研究为回顾性分析，纳入2020年6月至2024年6月期间在新乡市中心医院接受信迪利单抗联合贝伐珠单抗治疗的晚期实体肿瘤患者。收集患者的基本信息、药物相关不良反应以及随访数据。根据治疗过程中的不良反应发生情况，评估该联合治疗方案的安全性，并进行分组分析。结果：共纳入124例实体肿瘤患者，根据肿瘤类型将患者分为肝癌组（76例）和非小细胞肺癌组（48例）。肝癌组的客观缓解率（ORR）为10.5%，疾病控制率（DCR）为67.1%，其中PD-L1阳性组的ORR（P=0.021）及DCR（P=0.001）均显著高于PD-L1阴性组，年龄亚组未见显著差异（P均>0.05）。非小细胞肺癌组的ORR为31.3%，DCR为81.3%，其年龄亚组及PD-L1表达状态亚组均未见显著差异（P均>0.05）。肝癌组中75例（98.7%）患者发生任何级别的TRAE，39例（51.3%）患者发生≥3级的TRAE。肝癌组最常见的TRAE为蛋白尿（42.1%），血小板计数下降（40.8%），天冬氨酸转氨酶升高（36.8%），高血压（30.3%），血胆红素增加（28.9%），谷丙氨酸转氨酶升高（26.3%）；重度不良反应（CTCAE 3级及以上）主要为高血压和消化道出血。非小细胞肺癌组中48例（100.0%）患者发生任何级别的TRAE，20例（41.7%）患者发生≥3级的TRAE。非小细胞肺癌组最常见的TRAE为中性粒细胞计数下降（72.9%），白细胞计数下降（52.1%），贫血（58.3%），乏力（47.9%），恶心（45.8%），天冬氨酸转氨酶升高（45.8%），谷丙氨酸转氨酶升高（37.5%），呕吐（37.5%），蛋白尿（31.3%），血小板计数下降（31.3%），高血压（27.1%）；重度不良反应（CTCAE 3级及以上）主要为高血压和骨髓抑制。结论：信迪利单抗联合贝伐珠单抗在真实世界晚期实体肿瘤治疗中具有一定的安全性，伴随较高的不良反应发生率，但大多数为轻度。肝癌患者的治疗反应较非小细胞肺癌患者差，但PD-L1阳性患者的疗效明显优于PD-L1阴性患者。

Objective： Assessing the safety of sintilimab in combination with bevacizumab in real-world settings among patients with advanced solid tumours. Methods： This retrospective study included patients with advanced solid tumours who received sintilimab in combination with bevacizumab treatment at Xinxiang Central Hospital between June 2020 and June 2024. Patient demographics， drug-related adverse reactions and follow-up data were collected. The safety of the combination treatment regimen was evaluated based on the incidence of adverse reactions during treatment， with a subsequent subgroup analysis conducted.Results： A total of 124 patients with solid tumours were included in the study. The patients were divided into two groups based on tumour type： the hepatocellular carcinoma group （76 patients） and the non-small cell lung cancer group （48 patients）. The objective response rate （ORR） in the hepatocellular carcinoma group was 10.5%， with a disease control rate （DCR） of 67.1%. The PD-L1-positive subgroup demonstrated significantly higher ORR （P=0.021） and DCR （P=0.001） than the PD-L1-negative subgroup， and no significant differences were observed across age subgroups （all P values >0.05）. In the non-small cell lung cancer group， the ORR was 31.3%， with a DCR of 81.3%， and no significant differences were observed in the subgroups categorised by either age or PD-L1 expression status （P>0.05 for all）.In the hepatocellular carcinoma group， 75 patients （98.7%） experienced treatment-related adverse events （TRAEs） of any grade， and 39 patients （51.3%） experienced grade 3 or higher TRAEs. The most common TRAEs in patients with hepatocellular carcinoma were proteinuria （42.1%）， decreased platelet count （40.8%）， elevated aspartate transaminase （36.8%）， hypertension （30.3%）， increased serum bilirubin （28.9%） and elevated alanine aminotransferase （26.3%）. Severe adverse reactions （CTCAE grade 3 or higher） were primarily hypertension and gastrointestinal bleeding. In the non-small cell lung cancer group， all 48 patients experienced TRAEs of any grade， and 20 patients （41.7%） experienced grade 3 or higher TRAEs. The most common TRAEs in this group were decreased neutrophil count （72.9%）， decreased white blood cell count （52.1%）， anaemia （58.3%）， fatigue （47.9%）， nausea （45.8%）， elevated aspartate transaminase （45.8%）， elevated alanine transaminase （37.5%）， vomiting （37.5%）， proteinuria （31.3%）， decreased platelet count （31.3%）， and hypertension （27.1%）. Severe adverse reactions （CTCAE Grade 3 or higher） were primarily hypertension and bone marrow suppression.Conclusion： The combination of sintilimab and bevacizumab demonstrates an acceptable safety profile in real-world settings for advanced solid tumours， albeit with a relatively high incidence of adverse reactions， most of which are mild. The treatment response among patients with hepatocellular carcinoma is inferior to that observed in patients with non-small cell lung cancer， however， PD-L1-positive patients exhibit markedly superior efficacy compared to the PD-L1-negative patients.