Efficacy and safety of Yangxiao Fukang granule in the treatment of stage Ⅲ hepatitis B related liver cancer: study protocol for a randomized controlled trial.

Abstract

Primary liver cancer (PLC) is the third major cause of cancer related death, which seriously affects the survival period and quality of life of patients. However, there is currently no evidence to prove which treatment method is most effective. Traditional Chinese Medicine (TCM) has shown certain advantages in the treatment of PLC, especially in the side effects of Western Medicine. Therefore, we designed a clinical trial protocol for the treatment of PLC using TCM granules. Our purpose is to explore the efficacy and safety of Yangxiao Fukang granule (YXFKG, ) in the treatment of stage III hepatitis B related PLC. A total of 216 patients from three hospitals in Henan Province will be enrolled and randomly divided into a trial group and a control group in a 1∶1 ratio. The trial group will be treated with conventional western medicine plus YXFKG, while the control group will receive conventional western medicine plus a placebo for YXFKG. All patients will receive a daily dose of either YXFKG or a placebo for six months, followed by a six-month follow-up period. The main observation outcome includes 1-year survival rate, while secondary outcomes include conversion rate to remission, objective response rate, progression free survival, overall survival, quality of life score, and TCM clinical symptom score. Blood routine, urine routine, stool routine, electrocardiogram, liver and kidney function, coagulation function test, and D-dimer are safety indicators. Collect data before treatment and during the 3rd, 6th, 9th, and 12th months of treatment, and conduct statistical analysis. This study will preliminarily verify the effectiveness and safety of YXFKG in the treatment of stage III hepatitis B related PLC, which may provide a new choice for clinical treatment of PLC.