Abstract: Background and purpose: Apatinib is only approved for third-line treatment of advanced gastric cancer in China. However in recent years, antiangiogenic drugs have shown remarkable efficacy in a variety of advanced solid tumors. A large number of clinical studies have confirmed that the comprehensive treatment mode based on the combination of Chinese and Western medicine can achieve good results in anti-tumor treatment. The purpose of this study was to observe the short-term clinical efficacy and safety of apatinib combined with traditional Chinese medicine in the patients with stage Ⅳ malignant tumor after failure of second-line intervention. Methods: Twenty-one patients with advanced malignant tumor were recruited after second-line treatment from January 2016 to July 2017 in Department of Oncology, Longhua Hospital. Patients were administered with traditional Chinese medicine intravenous preparation and herbal decoction combined with apatinib of 500 mg once per day after failure of the secondline treatment. Each cycle was 28 d. Dose adjustment was made according to the National Cancer Institute classification of patients’ adverse reactions. The efficacy and toxicity of traditional Chinese medicine combined with apatinib and the survival of patients were analyzed. Results: In 21 cases, there were 6 cases of partial response (PR) and 15 cases of stable disease (SD). The overall response rate was 27.27%, and the disease control rate was 95.45%. There was no serious adverse reaction in all patients. The tumor markers including CEA, CA125, CYFRA211 and NSE were significantly decreased after treatment. The difference was statistically significant compared with those measured before the treatment (P<0.05). And no grade 4 side effect was found. Conclusion: To the patients with advanced malignant tumor who failed the second-line treatment, traditional Chinese medicine combined with apatinib is effective and well-tolerated. Our preliminary clinical data provides support for the further randomized controlled study with a large sample size.

Key words: Traditional Chinese medicine, Apatinib, Malignant tumor, Clinical effect