Survival outcomes of spleen-strengthening and dampness-eliminating traditional Chinese medicine granules combined with lenvatinib for unresectable hepatocellular carcinoma: a large-sample retrospective study based on electronic medical records.

BACKGROUND

Lenvatinib has been proven as a first-line systemic therapy for unresectable hepatocellular carcinoma (HCC). Traditional Chinese Medicine (TCM), particularly formulations targeting spleen strengthening and dampness elimination, has the potential for synergistic effects with targeted therapies. Researchers conducted a study to investigate the feasibility of combining spleen-strengthening and dampness-eliminating TCM granules with lenvatinib to improve survival rates in patients with unresectable HCC.

METHODS

This is a single-center retrospective cohort study that examined electronic medical records from one of the Beijing Royal Integrative Medicine Hospital between January 2023 and December 2025. Patients with unresectable HCC who received lenvatinib treatment as first-line therapy were divided into a combination group (TCM granules combined with lenvatinib, n = 186) and a control group (lenvatinib alone, n = 192). Balancing of baseline characteristics was done by use of propensity score matching (PSM). Overall survival (OS) was the primary endpoint; secondary endpoints included the incidence of adverse events, treatment duration, and the improvement of TCM syndromes.

RESULTS

Following 1:1 PSM, 156 patients were enrolled in each group. The combination group had a significantly longer median OS compared with the control group (18.7 months vs. 14.2 months; HR = 0.68, 95% CI: 0.52-0.89, P = 0.005). The incidence of Grade 3-4 adverse events was significantly lower in the combination group than in the control group (28.2% vs. 41.0%, P = 0.018). Treatment duration was significantly prolonged in the combination group (9.8 vs. 7.2 months, P = 0.012), and the combination group also showed better improvements in TCM syndrome scores.

CONCLUSIONS

Adjunctive therapy with spleen-strengthening and dampness-eliminating TCM granules was associated with better survival outcomes and fewer adverse events in patients with unresectable HCC receiving lenvatinib. These findings provide a rationale for prospective trials evaluating the integration of TCM into modern oncological treatment paradigms for HCC.