To investigate the clinical efficacy and safety of Huayu Pills in treating blood hypercoagulability in patients with advanced malignant tumors.Methods:Seventy-two blood hypercoagulability patients with advanced malignant tumors from the Oncology Department and inpatient wards of Beijing Hospital of Traditional Chinese Medicine between June 2018 and December 2021 were enrolled.A prospective cohort study design was used，and patients were divided into an observation group(n=35) and a control group(n=37) based on whether they received Huayu Pills.The control group received necessary physical symptomatic support，while the observation group received Huayu Pills orally for 8 weeks in addition to the support treatment.Both groups were followed for a total of 24 weeks.Improvement rates in blood hypercoagulability，changes in coagulation indicators，TCM syndrome scores，incidence of venous thromboembolism(VTE) and major bleeding，and adverse events of the two groups were observed.Results:After 4 weeks，the improvement rate of blood hypercoagulability in the observation group was 43.75%，higher than 29.41% in the control group(P>0.05).After 8 weeks，the improvement rate in the observation group was 65.63%，significantly higher than 41.18% in the control group(P<0.05).Further analysis showed that plasma fibrinogen(FIB) levels were lower in the observation group than the control group at both 4 and 8 weeks(P<0.05).The total effective rate of improvement in TCM syndrome score was 50.00% in the observation group and 14.81% in the control group(P<0.05).No major bleeding occurred in either group，and no drug-related adverse events were reported in the observation group.Conclusion:Huayu Pills，in addition to necessary physical support treatment，can further improve blood hypercoagulability and alleviate symptoms related to blood stasis in patients with advanced malignant tumors.