ObjectiveTo investigate the effects of lenvatinib combined with transarterial chemoembolization (TACE) and programmed death protein-1 (PD-1) monoclonal antibody (Abbreviated as LEN-TAP regimen) on residual liver volume and surgical safety in intermediate and advanced hepatocellular carcinoma (HCC). MethodsThe clinicopathologic data of patients with intermediate and advanced HCC were collected retrospectively, who underwent the LEN-TAP conversion therapy and surgical resection in the Department of Liver Surgery, West China Hospital, Sichuan University from October 2020 to December 2021. The total liver volume, tumor volume, and residual liver volume of the patients before and after conversion therapy were analyzed. ResultsA total of 48 patients were included, 26 of whom had partial remission and 22 had stable disease, the objective response rate was 54.2% (26/48) according to the Response Evaluation Criteria in Solid Tumours 1.1 after conversion therapy. Before and after conversion therapy, the total liver volumes including tumor were (1 607.15±712.22) mL and (1 558.03±573.89) mL [mean difference (MD) and 95% confidence interval (CI)=–57.42(–134.30, 19.46), t=–1.503, P=0.140], the total liver volumes excluding tumor tissue were (1 095.28±227.60) mL and (1 260.31±270.71) mL [MD(95%CI)=165.03(128.13, 201.93), t=8.997, P<0.001], the tumor volumes were 260.25(107.75, 699.50) mL and 121.73 (33.00, 332.88) mL [MD(95%CI)=–222.45(–296.46, –148.44), Z=–5.641, P<0.001], and the residual liver volumes were (493.62±154.51) mL and (567.83±172.23) mL [MD(95%CI)=74.21(54.64, 93.79), t=7.627, P<0.001], respectively. The increase rates of tumor volume and residual liver volume after conversion therapy were (–53.34±33.05)% and (16.34±15.16)%, respectively. The conversional resections were successfully completed in all patients, with 13 (27.1%) cases experiencing postoperative complications and without occurrence of postoperative liver failure. ConclusionThe data analysis results of this study indicate that the LEN-TAP conversion therapy can shrink tumor volume and increase the residual liver volume for patients with intermediate and advanced HCC, which helps to improve the safety of conversion resection.
Traditional Chinese medicine (TCM) is a treasure of the Chinese nation. Presence of clinical effects represents a fundamental issue for TCM development. Nevertheless, the complexities of TCM interventions often result in presented effects deviating from expected ones, a phenomenon so called as "effect off-target"; this issue has become a major challenge for the development and use of TCM interventions. In continuing efforts, we have proposed an innovative evidence-based medicine model for studying the effects of TCM interventions, termed "systems evidence-based medicine (sysEBM)". Essentially, the sysEBM model integrates clinical and non-clinical evaluation to develop a systematic pathway for studying effects of TCM interventions, and the methodological steps typically include the development of PICO framework for a putative effect, exploration of the effect and confirmation of the effect by using animal models, observational studies and clinical trials. As an additional step, multidisciplinary technologies including pharmaceutical, pharmacological, information and biological technologies will be used to provide multidimensional analyses of potential action networks and mechanisms of TCM interventions. Building on this concept, we have developed a sysEBM model ("6R" model) for acupuncture and marketed Chinese patent medicines by integrating real-world evidence, clinical trials, evidence syntheses, and rapid recommendation methodologies, as well as information technology and biomedical technologies. We also applied this model for developing TCM interventions for maternal health, critical care, and knee osteoarthritis.