Objective To observe the clinical efficacy of traditional Chinese medicine（TCM） compound LC09 granule soaking in the treatment of hand-foot skin reactions（HFSR） caused by anti-tumor targeted drug multikinase inhibitors. Methods A randomize-controlled trial method was used. A total of 66 cases of HFSR were randomly divided into a treatment group（44 cases） and a control group（22 cases）. The treatment group was treated with LC09 granule to dissolve and soak the skin of hands and feet at 40℃. The control group was given placebo soaking after dissolution

20 minutes each time

2 times a day for 7 days. Meanwhile

both groups were smeared with urea ointment after soaking

twice a day. After treatment

the effective rate and targeted drugs completion rate were compared between groups. Toxic event classification（NCI classification） before and after treatment

numerical rating scale（NRS） was used to evaluate pain degree

and HSFR quality of life scale（QOL） was scored. Results There were 2 cases drop off in the control group

1 case in the treatment group

and finally 43 cases were included in the treatment group and 20 cases were in the control group. The effective rate of the treatment group was 81.4%（35/43）

the targeted drug completion rate was 72.1%（31/43）

the effective rate of the control group was 45.0%（9/20）

and the targeted drug completion rate was 25.0%（5/20）. The effective rate and targeted drug completion rate of the treatment group were significantly higher than those of the control group（P<0.01）. After treatment

NRS

QOL score of the treatment group was significantly decreased（P<0.01）

and the NCI level was improved; while only QOL score was decreased in the control group（P<0.05）. Compared between groups

the treatment group was supperior in decreasing NRS and improving NCI level（P<0.05 or P<0.01）. Conclusion The TCM compound LC09 granule soaking combined with urea ointment can significantly improve the effective rate of HFSR

relieve pain

improve quality of life

reduce the rate of drug withdrawal of targeted drugs and the level of NCI.