Abstract： Objective： To observe the clinical effect of Xingqi Sanyu prescription combined with three- step hierarchy cancer pain management for cancer pain of malignant tumor. Methods： A total of 60 cases of patients with cancer pain of malignant tumor were selected and divided into the control group and the treatment group according to the random number table method， with 30 cases in each group. The control group was treated with three- step hierarchy cancer pain management of World Health Organization(WHO) for analgesia，and the treatment group was additionally treated with Xingqi Sanyu prescription based on the treatment of the control group. Both groups were observed for two cycles， with 14 days being a cycle. The clinical effects in the two groups were observed. The changes in Numerical Pain Rating Scale(NRS) scores and quality of life(QOL) before and after treatment as well as analgesic effect and analgesic drug dosage in the two groups were compared. During treatment，the incidences of adverse reactions in the two groups were observed. Results：After two cycles of treatment，the total effective rate of clinical effect was 93.33% in the treatment group，higher than that of 86.67% in the control group，there being no significant difference(P＞0.05). After two cycles of treatment，NRS scores in the two groups were decreased when compared with those before treatment，and NRS score in the treatment group was lower than that in the control group，differences being significant(P＜0.05). After two cycles of treatment，the onset time of analgesia in the treatment group was later than that in the control group，and the duration of analgesia was longer，the difference being significant(P＜0.05). During the treatment， the dosage of analgesic drugs including oxycodone hydrochloride sustained- release tablets and morphine hydrochloride tablets as well as the frequency of pain outbreak in the treatment group were lower than those in the control group， differences being significant(P＜0.05). During treatment， the incidence of adverse reactions such as nausea and vomiting， constipation， lack of strength， dizziness and somnolence was 13.33% in the treatment group and 40.00% in the control group，the difference being significant(P＜0.05). After two cycles of treatment， QOL scores of social function，physical function，role function and cognitive function in the two groups were increased when compared with those before treatment(P＜0.05)；the QOL scores of the above four dimensions in the treatment group were higher than those in the control group， differences being significant(P＜0.05). Conclusion： The therapy of Xingqi Sanyu prescription combined with three- step hierarchy cancer pain management for cancer pain of malignant tumor has a good analgesic effect，and can reduce the dosage of analgesic drugs and improve the quality of life，with high safety.