Abstract：Objective To evaluate the clinical efficacy of Huachansu injection via intra-tumorain injection for the treatment of superficial malignant tumors， and to explore the new method for local treatment of superficial malignant tumors. Methods Patients were collected and randomly assigned to groups. Huachansu injection or anhydrous ethanol was injected， or their combination， were administered by intra-tumoral injection to treat superficial malignant tumors. The tumor regression， clinical score， immune marker levels， and safety were observed.  Results There were no significant differences in the local control efficacy between the Huachansu group and the combination group （χ2＝ 0.800， P＝0.371）， but both groups showed significant improvement compared to the anhydrous ethanol group （χ2＝7.729， P＝0.005; χ2＝12.500， P＜0.001）. After treatment， the Karnofsky Performance Status （KPS） score， the Quality of Life Questionnaire C30 （QLQ-C30） score， and the MDASI-TCM syndrome score in the Huachansu group were significantly lower than those in the anhydrous ethanol group （F＝6.251， 7.025， 16.325； all P＜0.01）. The KPS score and MDASI-TCM syndrome score in the combination group were significantly lower than those in the anhydrous ethanol group （F=5.687， 11.268， both P＜0.01）， while the QLQ-C30 score showed no significant change （F＝0.528， P＞0.05）. After treatment， the vascular endothelial growth factor （VEGF） levels in the Huachansu and combination groups were significantly lower than those in the anhydrous ethanol group （F=16.375， 14.358， both P＜0.001）. The immune markers in the Hua Chansu and combination groups were significantly better than in the anhydrous ethanol group （F＝13.291， 11.287， 5.327， 8.354， 3.724； all P＜0.05）， but there were no significant differences between the Huachansu and combination groups （all P＞0.05）.  Conclusion Local injection therapy with Huachansu injection had a significant inhibitory effect on superficial tumors， enhanced cellular immune function， and promoted tumor tissue necrosis.