Yangyin Fuzheng Jiedu prescription as an adjunct to minimally invasive treatment in early-stage hepatocellular carcinoma: a randomized controlled trial

Background and Aims: Recurrence remains common after minimally invasive treatment in patients with early-stage hepatocellular carcinoma (HCC). This randomized controlled trial evaluated the efficacy and safety of Yangyin Fuzheng Jiedu Prescription (YFJP) as an adjunct to minimally invasive treatment in early-stage HCC. Method: In this randomized controlled trial, 300 patients with early-stage HCC (BCLC stage 0-A) undergoing minimally invasive treatment were randomly assigned (1:1) to receive YFJP plus minimally invasive treatment (YFJP group) or minimally invasive treatment alone (Control group). Patients were followed for 48 weeks. The primary endpoint was recurrence-free survival (RFS). RFS was assessed using the Kaplan-Meier method and compared with the log-rank test. Cox proportional hazards models were used for exploratory subgroup analyses. Safety was evaluated by the incidence of adverse events. Result: At 48 weeks, outcome data were available for 135 patients in the YFJP group and 137 patients in the Control group. Recurrence-free survival was significantly longer in the YFJP group than in the Control group (log-rank p = 0.016). Subgroup analyses showed a generally consistent direction of treatment effect across clinical subgroups, although the magnitude of effect varied. The incidence of adverse events was similar between groups, with no unexpected safety signals observed. Conclusion: In patients with early-stage HCC undergoing minimally invasive treatment, adjunctive treatment with YFJP was associated with improved recurrence-free survival over 48 weeks without compromising safety. These findings support the potential role of YFJP as an adjunctive therapeutic option in early-stage HCC. Clinical Trial Registration: https://clinicaltrials.gov/, Identifier NCT04264962.