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Real-World Safety Assessment and Analysis of Sintilimab Combined with Bevacizumab for the Treatment of Advanced Solid Tumours
Received date: 2025-09-10
Revised date: 2026-01-02
Accepted date: 2026-05-26
Online published: 2026-05-26
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.
Key words： Sintilimab； ; Bevacizumab； ; Advanced solid tumours； ; Safety； ; Real-world
LIU Xi, ZHANG Tiandong, WANG Peishan, ZHANG Guifang
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Real-World Safety Assessment and Analysis of
Sintilimab Combined with Bevacizumab for the Treatment of Advanced Solid
Tumours
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