Safety evaluation of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma
- VernacularTitle:信迪利单抗联合化疗用于胆管癌的安全性评价
- Author:
Hao ZHONG
1
;
Hang LIN
1
;
Yaxin LU
2
;
Haiyan MAI
1
Author Information
1. Dept. of Pharmacy，the Third Affiliated Hospital of Sun Yat-sen University，Guangzhou 510630，China
2. Big Data and Artificial Intelligence Center，the Third Affiliated Hospital of Sun Yat-sen University，Guangzhou 510630，China
- Publication Type:Journal Article
- Keywords:
sintilimab;
chemotherapy;
cholangiocarcinoma;
safety evaluation;
thrombocytopenia
- From:
China Pharmacy
2025;36(4):482-485
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To assess the safety profile of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma. METHODS The data of patients with cholangiocarcinoma from January 1st， 2021 to December 31st， 2022 were collected and divided into control group （29 cases） and observation group （18 cases） based on different medication regimens. Patients in the control group were treated with Gemcitabine hydrochloride for injection+Cisplatin for injection or Oxaliplatin for injection， the observation group was treated with Sintilimab injection based on the control group. Patients in each group underwent blood routine， liver and kidney function， biochemical and other examinations before and after each treatment cycle to observe the occurrence of adverse drug reactions. The correlation of adverse drug reactions with drugs was evaluated with Naranjo’s scale. RESULTS The correlation between blood toxicity and drug use was deemed “probable” in both groups； however， the observation group exhibited a significantly higher score， indicating a stronger correlation. In the control group， hepatotoxic reactions were classified as “suspicious” whereas in the observation group， they were categorized as “probable”. The correlation of gastrointestinal symptoms between the two groups was considered “possible”. Systemic symptoms， skin toxicity， musculoskeletal toxicity， endocrine toxicity and renal toxicity were all classified as having a “suspicious” correlation with drug use. The total incidence of blood toxicity in the observation group was significantly higher than control group （P＝0.014）. There was no statistically significant difference in the total incidences of hepatotoxic， gastrointestinal symptoms， systemic symptoms， skin toxicity， musculoskeletal toxicity， endocrine toxicity， renal toxicity， or the incidence of grade 3 or higher blood toxicity， hepatotoxic between the two groups （P＞0.05）. For the patients experiencing adverse drug reactions， the symptoms were alleviated following drug discontinuation or symptomatic supportive treatment. No fatalities occurred during the treatment period. CONCLUSIONS Sintilimab combined with chemotherapy may significantly increase the risk of blood toxicity in patients with cholangiocarcinoma， especially thrombocytopenia， but the adverse reactions are within a controllable range， and the overall safety is good.
