| Update the RCT data of Quxie Capsules in early stage, and verify the efficacy and safety of Quxie Capsules in the treatment of patients with metastatic colorectal cancer (mCRC). Methods:From April 1, 2014 to July 31, 2015, a total of 60 patients with advanced colorectal cancer and clear pathological diagnosis in the outpatient and inpatient Department of Oncology Department of Xiyuan Hospital, China Academy of Chinese Medical Sciences were selected as the research objects. The subjects were divided into a treatment group and a control group by a randomized, double-blind, placebo-controlled method, with 30 cases in each group. The treatment group was treated with Quxie Capsules combined with conventional treatment, and the control group was treated with Quxie Capsules placebo combined with conventional treatment. Long-term follow-up was after 3 months of treatment, the overall survival, progression-free survival, safety indicators and adverse reactions of the 2 groups were observed.Results:Follow-up until February 20, 2021, all subjects reached the clinical endpoint. The longest follow-up time was 74 months. The median survival time of the treatment group was 9.6 months longer than that of the control group (23.9 vs. 14.3, P=0.032). The median progression-free survival in both groups was 6 months, and the difference was not statistically significant (P=0.60). In the colon subgroup, left colon subgroup, second-line and above second-line treatment subgroup, non-targeted therapy subgroup, and RAS wild-type subgroup, the difference in OS between the treatment group and the control group was statistically significant (P=0.018, 0.037, 0.007, 0.022, 0.019); in the chemotherapy subgroup, the overall survival of the treatment group was prolonged by 9.7 months compared with the control group, the clinical benefit was obvious, and the difference was trending (P=0.072). Quxie capsules are safe. Conclusion:Quxie Capsules can prolong the survival and safety of patients with advanced colorectal cancer with good safety. |
