Clinical trial of the JC724 combined capecitabine on advanced cancer
1,2RAO Ben-qiang, 3DING Yan, 2DENG Li
1Department of General Surgery/Medical Oncology Center, Aviation General Hospital/Beijing Institute of Translational Medicine, Chinese Academy of Sciences, Beijing 100012, China; 2Institute of Gastrointeology, Third Affilliatted of Nanchang University, Nanchang 330006, China; Operation Room, 105 Hospital of the People’s Liberation Army, Hefei 230031, China
Abstract：Objective Cell experiment showed that the combined use of JC724 extracted from natural plant compounds and 5-Fu had a synergistic antitumor effect. The clinical effects and side effects of JC724 combined with capecitabine in the treatment of pancreatic cancer, colorectal cancer and other advanced cancer were observed, and the dose and safety of JC724 in the treatment of advanced tumors were determined. Methods 35 patients with advanced colorectal cancer, pancreatic cancer and other tumors were treated using JC724 combined with capecitabine. Capecitabine was administered orally at a dose of 1,250 mg/m2 twice daily for 14 days followed by 7 days of rest (one cycle), and JC724 was administered 2 times a day in three different oral doses, 800mg, 1,000mg and 1,200mg. The evaluation indexes were tumor response and patient’s tolerance to the treatment. Results Totally 35 advanced cancer patients were 21 males, 14 females, with the average age of 62.3 years, 3 cases of pancreatic carcinoma, 18 cases of colorectal cancer, 3 cases of primary liver cancer, 1 cases of bile duct cancer, 7 cases of gastric cancer, 2 cases of breast cancer, 1 cases of metastatic liver cancer with unknown origin. The ECOG score of 0~1 in 30 cases, 2 points in 5 cases. All patients completed 132 cycles of capecitabine in the treatment (median 3.77 cycle, 1~6 cycle), and 134 cycles JC724 (median 3.83 cycles, 1~6 cycles ). Only one DLT was observed in 1,200mg group, which 1,000mg would be determined as the maximum dose of JC724. 3 patients had PR, 20 patients had SD for more than 8 weeks. Conclusions JC724 combined with capecitabine in the treatment of advanced cancer patients could obtain better curative effect, in which oral dose of JC724 1,000mg, 2 times a day for up to 1~14 days, was safe and effective, but further research was needed.
