413 Background: Combination therapy with tyrosine kinase inhibitors and anti-PD-1 antibodies can allow selected patients with initially unresectable HCC to convert to surgical resection. We evaluated conversion therapy with a triple combination of lenvatinib (LEN), anti-PD-1 antibodies and transarterial therapy. Methods: We retrospectively searched medical records from 117 consecutive patients with unresectable/advanced HCC who received triple combination therapy between Dec 2018 and Oct 2020 at Tianjin Medical University Cancer Institute & Hospital. Eligible patients were required to have potentially resectable HCC, defined as meeting ≥1 of the following criteria: 1) estimated future liver remnant after radical (R0) resection of < 40% or < 30% in patients with/without cirrhosis, respectively; 2) R0 resection technically difficult to complete; 3) Child-Pugh score ≥7, ECOG performance status ≥1; 4) tumor thrombus in the main portal vein or inferior vena cava; 5) resectable extrahepatic metastases. The primary endpoint was the proportion of patients who underwent a successful resection (conversion rate). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), 6-month disease-free survival (DFS) and safety. Results: Of 37 patients included in the analysis, all received LEN and anti-PD-1 antibodies with transarterial chemoembolization (TACE, n = 22), hepatic arterial infusion chemotherapy (HAIC, n = 9) or both (n = 6). The conversion rate was 40.5% (15) and the ORR and DCR were 67.7% and 86.5% by RECIST v1.1 and 75.7% and 86.5% by mRECIST, respectively. The median conversion time was 4 months (range: 2-15). After a median postoperative follow-up time of 10 months (95% CI, 6.42-13.58), the 6-month DFS rate was 93%. Overall, 89.2% of patients had ≥1 treatment emergent adverse event (TEAE) and 29.7% experienced a Grade 3/4 TEAE, the most common was hypertension (18.9%, n = 7). Conclusions: A triple combination of LEN, anti-PD-1 antibodies and transarterial therapy was well tolerated and effective at converting potentially resectable HCC to resectable disease. These findings warrant confirmation by future prospective studies.

Purpose The purpose of this study was to investigate the triple-combination therapy of lenvatinib plus sintilimab plus arterially-directed therapy as a conversion therapy for initially unresectable hepatocellular carcinoma (HCC). Patients and Methods We retrospectively analyzed data from all HCC patients who underwent lenvatinib plus sintilimab plus arterially-directed therapy at Tianjin Medical University Cancer Hospital between December 2018 and October 2020. Of 98 enrolled patients, 37 patients were classified as potentially resectable. We compared the potentially resectable population (PRP) with the non-potentially resectable population (NPRP). The primary study endpoint was conversion rate, and secondary endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Results The baseline characteristics were comparable between populations except for a higher proportion of patients with extrahepatic metastases in the NPRP versus PRP (23/61 [37.7%] vs 3/37 [8.1%], respectively; p=0.003). For PRP, the ORR was 67.6% based on RECIST v1.1 (75.7% based on mRECIST), conversion rate was 40.5% (15/37). Of the 15 patients who underwent surgical resection, three achieved complete pathological remission. The median follow-up for all patients was 28 months (range: 2–47). For NPRP, the ORR was 22.9% based on RECIST v1.1 (31.1% based on mRECIST), The median PFS for PRP was significantly longer than that of NPRP (25 vs 13 months, p = 0.0025). The median OS for PRP was significantly longer than that of NPRP (not reached VS 21 months, p=0.014). Hypertension was the most common grade ≥3 adverse reaction in both PRP and NPRP. No new safety signals were observed for any of the treatments. Conclusion The triple-combination therapy of lenvatinib plus sintilimab plus arterially-directed therapy can convert potentially unresectable HCC into resectable disease and improve long-term survival.

Background: Regorafenib is a standard 2nd-line treatment for patients with advanced hepatocellular carcinoma (HCC), but the efficacy and safety of sequential therapy with sorafenib and regorafenib among advanced HCC patients in China is not clear.Methods: This was a retrospective, two-center, cohort study of advanced HCC patients who received sequential therapy of sorafenib and regorafenib from October 2018 to April 2020 at 2 Chinese institutions.The patients were converted directly to regorafenib after failing to respond to sorafenib monotherapy.The patients underwent evaluations every 4-6 weeks to determine the efficacy and safety of the treatment according to physiological, laboratory, and radiological results. A radiological evaluation using computed tomography or magnetic resonance imaging scans was conducted. The outcomes included overall survival (OS) and progression-free survival (PFS).Results: A total of 43 patients received regorafenib as a 2nd-line treatment after sorafenib progression.Of these patients, 26 (60.5%) and 17 (39.5%) were diagnosed with Barcelona Clinic Liver Cancer (BCLC) stages B and C, respectively. The median PFS was 11.0 [95% confidence interval (CI): 5.8-16.2] months, and the median OS was 17.0 (95% CI: 12.8-21.2) months. Conversely, the most common toxicities were hand-foot skin reaction (48.8%), diarrhea (32.6%), and hypertension (14%). The most common grade 3-4 toxicities were hypoalbuminemia (4.7%), anemia (4.7%), and thrombocytopenia (4.7%). Alpha-fetoprotein (AFP) ≥400, alanine transaminase (ALT) ≥60 IU/L, and aspartate aminotransferase (AST) ≥60 IU/L before 2nd-line treatment were associated with PFS in the univariable analyses. The Cox proportional-hazards regression analysis showed that AFP [hazard ratio (HR) =0.

Purpose This study aimed to explore the relationship between the tumor marker score (TMS) and the postoperative recurrence of single small hepatocellular carcinoma (HCC). Patients and Methods A total of 409 patients with one resectable HCC with a diameter of 3 cm or less who visited Tianjin Medical University Cancer Institute & Hospital from January 2010 to December 2014 were included in this study. Their alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and carbohydrate antigen 19-9 (CA19-9) levels were classified into low and high groups using X-tile software. Each patients' TMS was calculated as the sum of each tumor marker (low = 0; high = 1). Results A total of 142 patients were classified as TMS0, 171 as TMS1, and 96 as TMS2. Kaplan–Meier analysis illustrated that TMS could divide the patients into groups with remarkably different prognoses, and the patients with high TMS had worse recurrence-free survival (RFS) than those with low TMS. Multivariate analysis showed that TMS, age, and HBeAg positive were the independent predictors of RFS rate. Subgroup analysis revealed that high TMS was a stable risk factor relative to TMS0. Receiver operating curves showed that the 1-, 3-, and 5-year area under curve (AUC) values of TMS were 0.698, 0.662, and 0.673, respectively. The AUC of TMS was higher than that of other common prognostic models in time-dependent receiver operating curve. Conclusion TMS was an independent prognostic factor for the postoperative recurrence of a single small HCC and can provide a well-discriminated risk stratification, thus contributing to prognostic prediction and adjuvant therapeutic development.

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