Background The rise in cholangiocarcinoma (CCA) cases and deaths in China necessitates new treatments. This investigation is designed to establish the comparative efficacy between the coupling of immune checkpoint inhibitors (ICIs) paired with chemotherapy and chemotherapy alone for Chinese individuals diagnosed with CCA. Method Web of Science, Embase, Scopus, the Cochrane Library and PubMed databases were scanned systematically, spanning their initial establishment through June 2025. Overall survival (OS) and progression-free survival (PFS), the primary outcome measures, were demonstrated by the included studies. Included studies specified objective response rate (ORR), adverse events (AEs), and disease control rate (DCR) as secondary endpoints. Engauge Digitizer 11.3 extracted survival curve data points for studies with sole curve data. Calculated: log (HR) = ln (HR), <InlineEquation ID="IEq1"> <EquationSource Format="TEX">\(\:\text{S}\text{E}\left(\text{l}\text{o}\text{g}\right(\text{H}\text{R}\left)\right)=\sqrt{\text{V}}\)</EquationSource> </InlineEquation>,<InlineEquation ID="IEq2"> <EquationSource Format="TEX">\(\:\text{V}=\text{V}\text{a}\text{r}\left(\text{l}\text{o}\text{g}\right(\text{H}\text{R}\left)\right)\)</EquationSource> </InlineEquation>. Results The synthesis of the research incorporated findings from eight studies, which altogether assessed 802 cases of cholangiocarcinoma. Combining ICIs with chemotherapy markedly enhanced survival duration. OS had a hazard ratio of 0.46 (95% CI, 0.30–0.58; P < 0.001). PFS had a HR of 0.56 (95% CI, 0.46–0.67; P < 0.001). Higher ORR and DCR were also noted with combination therapy (ORR: risk ratio [RR], 1.34; 95% CI, 1.22–1.48; P < 0.001; DCR: RR, 2.46; 95% CI, 1.84–3.29; P < 0.001). Combination therapy was found, via Kaplan-Meier curves, to significantly increase OS (HR = 0.46, 95% CI 0.39–0.53; P < 0.001); PFS (HR = 0.38, 95% CI 0.35–0.46; P < 0.001). Sensitivity analysis validated stable, OS: HR = 0.46 (95% CI 0.36–0.58, P < 0.001); PFS: HR = 0.56 (95% CI 0.46–0.67, P < 0.001) for ICIs plus chemotherapy treatment. Conclusions Adding ICIs to chemotherapy for advanced CCA in China enhances treatment response and survival, without added adverse effects, offering a beneficial and tolerable therapeutic alternative for advanced and recurrent CCA.

Immunotherapy checkpoint inhibitor-combination therapy versus chemotherapy alone among Chinese population in cholangiocarcinoma treatment: a systematic review and meta-analysis

期刊论文
发表日期：

2026年1月17日

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Li Shi,
Wei Du,
Juan Miao,
Xi-Yuan Peng,
Wei Li,
Attiq Ur-Rehman,
Meng-Wei Ge,
Lu-Ting Shen,
Rui Feng,
Kang Zhong,
Si-Qi Gao,
Hong-Lin Chen

摘要

Background

The rise in cholangiocarcinoma (CCA) cases and deaths in China necessitates new treatments. This investigation is designed to establish the comparative efficacy between the coupling of immune checkpoint inhibitors (ICIs) paired with chemotherapy and chemotherapy alone for Chinese individuals diagnosed with CCA.

Method

Web of Science, Embase, Scopus, the Cochrane Library and PubMed databases were scanned systematically, spanning their initial establishment through June 2025. Overall survival (OS) and progression-free survival (PFS), the primary outcome measures, were demonstrated by the included studies. Included studies specified objective response rate (ORR), adverse events (AEs), and disease control rate (DCR) as secondary endpoints. Engauge Digitizer 11.3 extracted survival curve data points for studies with sole curve data. Calculated: log (HR) = ln (HR), \(\:\text{S}\text{E}\left(\text{l}\text{o}\text{g}\right(\text{H}\text{R}\left)\right)=\sqrt{\text{V}}\) , \(\:\text{V}=\text{V}\text{a}\text{r}\left(\text{l}\text{o}\text{g}\right(\text{H}\text{R}\left)\right)\) .

Results

The synthesis of the research incorporated findings from eight studies, which altogether assessed 802 cases of cholangiocarcinoma. Combining ICIs with chemotherapy markedly enhanced survival duration. OS had a hazard ratio of 0.46 (95% CI, 0.30–0.58; P < 0.001). PFS had a HR of 0.56 (95% CI, 0.46–0.67; P < 0.001). Higher ORR and DCR were also noted with combination therapy (ORR: risk ratio [RR], 1.34; 95% CI, 1.22–1.48; P < 0.001; DCR: RR, 2.46; 95% CI, 1.84–3.29; P < 0.001). Combination therapy was found, via Kaplan-Meier curves, to significantly increase OS (HR = 0.46, 95% CI 0.39–0.53; P < 0.001); PFS (HR = 0.38, 95% CI 0.35–0.46; P < 0.001). Sensitivity analysis validated stable, OS: HR = 0.46 (95% CI 0.36–0.58, P < 0.001); PFS: HR = 0.56 (95% CI 0.46–0.67, P < 0.001) for ICIs plus chemotherapy treatment.

Conclusions

Adding ICIs to chemotherapy for advanced CCA in China enhances treatment response and survival, without added adverse effects, offering a beneficial and tolerable therapeutic alternative for advanced and recurrent CCA.