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Meta-Analysis of the Efficacy and Safety of Sintilimab in Combination With Chemotherapy for Advanced Non-Small-Cell
Liling Pan1, Qiongqing Chen1, Ningsheng Liang1
1Department of Pharmacy, Guangxi Medical University Cancer Hospital, Nanning, China.
Objective:
Sintilimab is an innovative immune checkpoint inhibitor (ICI), domestically produced in China, that exhibits significant efficacy in the treatment of lung cancer. However, due to the delayed initiation of ICI development in China, its use is currently restricted to domestic markets, resulting in a limited volume of clinical data, which poses a challenge in postmarketing evaluation. This study aimed to assess the safety and efficacy of sintilimab through a meta-analysis.
Methods:
We conducted independent searches for relevant articles in both Chinese and international databases, followed by independent screening, after which the data were extracted from the selected studies. Statistical analysis was performed using RevMan software, version 5.4, and the results were estimated using the risk ratio with 95% confidence interval.
Results:
Efficacy analysis revealed that sintilimab, when combined with chemotherapy, significantly enhanced the objective response rate and disease control rate in patients with non-small-cell lung cancer (NSCLC) while reducing the risk of disease progression. Evaluation of the safety of sintilimab revealed that the risks of hypothyroidism, pneumonia, and rash in patients with advanced NSCLC following treatment were higher than those of the control group by 3.70-fold, 2.22-fold, and 1.58-fold, respectively. There were no significant differences between the combination therapy and chemotherapy groups in terms of the incidence of blood system toxicity, impairment of liver function, and fever; however, nausea, vomiting, and diarrhea appeared to be less severe in the combination therapy group.
Conclusions:
Sintilimab, combined with chemotherapy, demonstrates promising efficacy in the treatment of advanced NSCLC; however, it is imperative to closely monitor for adverse events, particularly immune-related adverse events.
Clinical Trial Registration:
Not available.
Insights
Sintilimab combined with chemotherapy shows effectiveness in treating non-small-cell lung cancer (NSCLC). Close monitoring for immune-related adverse events is crucial alongside its promising efficacy in NSCLC treatment.
Area of Science:
- Oncology
- Immunotherapy
- Pharmacology
Background:
- Sintilimab is a Chinese-produced immune checkpoint inhibitor (ICI) effective for lung cancer.
- Limited postmarketing data exists for sintilimab due to delayed development and domestic market restrictions.
- A meta-analysis is needed to evaluate sintilimab's safety and efficacy.
Purpose of the Study:
- To assess the safety and efficacy of sintilimab in lung cancer treatment through a meta-analysis.
- To consolidate existing clinical data for a comprehensive evaluation.
- To provide insights for postmarketing surveillance of sintilimab.
Main Methods:
- Searched Chinese and international databases for relevant studies.
- Conducted independent screening and data extraction.
- Performed statistical analysis using RevMan 5.4, estimating risk ratios with 95% confidence intervals.
Main Results:
- Sintilimab plus chemotherapy significantly improved objective response and disease control rates in non-small-cell lung cancer (NSCLC).
- Increased risks of hypothyroidism (3.70-fold), pneumonia (2.22-fold), and rash (1.58-fold) were observed with sintilimab.
- No significant differences in blood toxicity, liver function, or fever; reduced nausea, vomiting, and diarrhea noted with combination therapy.
Conclusions:
- Sintilimab combined with chemotherapy shows promise for advanced NSCLC treatment.
- Close monitoring for adverse events, especially immune-related ones, is essential.
- The findings support sintilimab's role in NSCLC therapy while highlighting safety considerations.
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