Efficacy of anlotinib plus immune checkpoint inhibitors in soft-tissue sarcoma: systematic review and meta-analysis.

BACKGROUND: Advanced or metastatic soft-tissue sarcoma (STS) responds poorly to standard chemotherapy. Anlotinib has shown activity across multiple treatment lines, including first-line and maintenance therapies, though monotherapy benefit remains limited. This study aimed to quantify the efficacy of anlotinib plus PD-1/PD-L1 inhibitors in advanced or metastatic soft-tissue sarcoma (STS). METHODS: We conducted a PRISMA-adherent systematic review of PubMed, Scopus, and Web of Science from inception to October 2025. Studies enrolling adults with advanced or metastatic STS treated with anlotinib plus a PD-1/PD-L1 inhibitor were eligible. Pooled analyses were performed in R using the meta package under inverse-variance random-effects models. RESULTS: Seven studies were included. The pooled objective response rate was 37.3% (95% CI, 17.0-60.4), and the pooled disease control rate was 77.2% (95% CI, 71.7-82.4). Complete and partial responses occurred in 4.3% (95% CI, 1.4-8.8) and 29.9% (95% CI, 13.4-49.6), respectively, with stable disease in 50.6% (95% CI, 39.5-61.8). The pooled 6-month progression-free survival (PFS-6) rate was 61.1% (95% CI, 22.1-93.1). CONCLUSION: Among advanced or metastatic STS cohorts, combination therapy with anlotinib and PD-1/PD-L1 inhibitors showed encouraging objective responses and disease control. These outcomes appeared numerically higher than those historically reported with monotherapy, although the evidence remains limited by small sample sizes, non-randomized designs, and histologic heterogeneity. PROTOCOL REGISTRATION: PROSPERO (URL: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251232427), identifier is CRD420251232427.