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432 Background: Half of the new cases and deaths of HCC was observed in China all over the world in 2020. However, the prognosis of traditional treatments for patients (pts) with HCC was dismal currently. Small-molecule anti-angiogenesis targeted drugs and PD-1 blockades were proved to demonstrate potential efficacy in advanced primary HCC. Anlotinib was a novel oral multi-targeted tyrosine kinase inhibitor for tumor angiogenesis and proliferation, which had been licensed for treatment of considerable malignancies in China. However, the real-world evidence of anlotinib and PD-1 blockades in HCC was still scanty currently. Consequently, the aim of this study was to investigate the efficacy and toxicity of anlotinib with or without PD-1 blockades in the treatment of advanced primary HCC in real-world. Methods: Pts with advanced primary HCC who received at least 2 cycles of anlotinib (8̃12mg, po, d1̃14, q3w) were recruited in this study. Clinical efficacy and survival data was summarized, adverse events were documented retrospectively. The tumor response was assessed by investigator according to RECIST version 1.1 using CT scans. The primary endpoint was objective response rate (ORR), secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. Results: From Jul 2019 to May 2021, a total of 28 eligible pts were screened. Among them, 12 pts received anlotinib as first-line treatment, 9 pts as second-line treatment and 7 pts as third-line treatment and above. In best overall response assessment, there were 5 CR (17.8%), 2 PR (7.1%), 13 SD (46.4%), 7 PD (25.0%) and 1 NE (3.5%). ORR was 25.0% (95%CI: 10.7̃44.9%) and DCR was 71.4% (95%CI: 55.3̃86.8%). At the data cut-off date, 15 pts discontinued treatment due to disease progression, the preliminarily prognostic results indicated that the median PFS of the 28 pts was 4.93 months (95%CI: 1.60̃8.26), and the median OS was 13.21 months (95%CI: 10.77̃15.65). Specifically, 14 pts combined with PD-1 blockades treatment, ORR was 28.6% (95%CI: 8.4̃58.1%) and DCR was 71.4% (95%CI: 41.9̃91.6%). The remaining 14 pts failed to receive PD-1 blockade combination therapy with the ORR of 21.4% (95%CI: 4.7̃50.8%) and DCR of 71.4% (95%CI: 41.9̃91.6%). The safety profile suggested that the most common drug-related adverse events were decreased appetite, fatigue, thrombocytopenia, hypertension, diarrhea, anemia, hand-foot syndrome, proteinuria and bleeding. The common grade 3 adverse event was bleeding (10.7%). Conclusions: Present study indicated that anlotinib-related regimens in the treatment of advanced primary HCC exhibited potential efficacy and manageable adverse events in real-world setting. The conclusion should be validated in more pts included subsequently.