This randomized phase II trial showed sorafenib plus 3cir-OFF hepatic arterial infusion chemotherapy improved overall survival compared with sorafenib alone in patients with advanced hepatocellular... Background The prognosis of hepatocellular carcinoma (HCC) with major portal vein tumor thrombosis (PVTT) is dismal after standard treatment with sorafenib. Hepatic arterial infusion chemotherapy (...

This open-label phase II trial (NCT04542837) aimed to evaluate the efficacy and safety of KN046 combined with lenvatinib in patients with advanced hepatocellular carcinoma (HCC), and explore the potential response biomarkers. Participants received KN046 5 mg/kg every 3 weeks and lenvatinib 12 or 8 mg once daily. The primary endpoints were safety, tolerability, dose-limiting toxicity (DLT), and objective response rate (ORR) according to RECIST v1.1. A total of fifty-five participants were enrolled. The results meet the pre-specified primary endpoints. No DLT was observed in the safety run-in period. The incidence of serious adverse events and grade ≥3 treatment-related adverse events (TRAEs) was 30.9% and 47.3%, respectively. Grade ≥3 immunotherapy-related adverse events occurred in 3 (5.5%) participants. Five (9.1%) participants discontinued treatment due to TRAEs, all of which were grade 1-2. The ORR was 45.5% (95% CI, 31.97-59.45). The median progression-free survival was 11.0 (95% CI, 8.21-15.24) months. The median overall survival (OS) was 16.4 (95% CI, 11.20-not estimable) months, and 12-month OS rate was 60.0% (95% CI, 45.87-71.55). Circulating tumor DNA status before the third cycle of treatment was associated with prognosis. In conclusion, First-line KN046 plus lenvatinib shows promising efficacy for advanced unresectable or metastatic HCC.

Background: Patients with a 5‐year recurrence‐free survival post liver resection for colorectal cancer liver metastases (CRLM) are considered to be potentially cured. However, there is a deficit of data on long‐term follow‐up and the recurrence status among these patients in the Chinese population. We analyzed real‐world follow‐up data of patients with CRLM who underwent hepatectomy, explored the recurrence patterns, and established a prediction model for a potential cure scenario.Methods: Patients who underwent radical hepatic resection for CRLM during 2000–2016, with actual follow‐up data for at least 5 years, were enrolled. The observed survival rate was calculated and compared among the groups with different recurrence patterns. The predictive factors for 5‐year non‐recurrence were determined using logistic regression analysis; a recurrence‐free survival model was developed to predict long‐term survival.Results: A total of 433 patients were included, of whom 113 patients were found non‐recurrence after 5 years follow‐up, with a potential cure rate of 26.1%. Patients with late recurrence (>5 months) and lung relapse showed significantly superior survival. Repeated localized treatment significantly improved the long‐term survival of patients with intrahepatic or extrahepatic recurrences. Multivariate analysis showed that RAS wild‐type CRC, preoperative CEA <10 ng/ml, and liver metastases ≤3 were independent factors for a 5‐year disease‐free recurrence. A cure model was developed based on the above factors, achieving good performance in predicting long‐term survival.Conclusions: About one quarter patients with CRLM could achieve potential cure with non‐recurrence at 5‐year after surgery. The recurrence‐free cure model could well distinguish the long‐term survival, which would aid clinicians in determining the treatment strategy.

The aim was to identify the optimal criteria of postoperative complications (POCs) for predicting oncological outcomes after hepatectomy for colorectal liver metastases (CRLMs) and to investigate the variable prognostic implications of POCs according to the modified clinical score (M-CS). We identified 751 patients who underwent curative hepatic resection for CRLM between 2007 and 2018. Patients were categorized based on the M-CS. The impact of the severity [≥ Clavien–Dindo grade (C–D) III or comprehensive complication index (CCI) ≥ 26.2] or type [any infectious complications of POC (Inf-poc)] of POC on overall survival (OS) and recurrence-free survival (RFS) was assessed by univariate and multivariable analyses in different groups. Patients with a major or infectious complication were not associated with either RFS or OS in multivariable analysis of the whole cohort. However, patients with a high CCI had a worse OS (HR 1.51,P = 0.004). Among patients with low M-CS, patients with high CCI had worse OS (HR 1.49,P = 0.035) and RFS (HR 1.32,P = 0.048) than those without high CCI. In contrast, the survival disadvantage of a high CCI was not present in patients with a high M-CS. Compared to Inf-poc or major complications, a high CCI decreased long-term OS in patients treated with hepatectomy for CRLM. High CCI has a variable prognostic impact after hepatic resection for CRLM depending on the M-CS. POC is not a decisive factor to justify the use of hepatectomy for CRLM in patients with high M-CS.

To evaluate the outcomes of percutaneous intervention (PI) for transplant renal artery stenosis (TRAS). Doppler ultrasonography was used as the screening tool, and angiography was the diagnostic method for TRAS. The indications for PI were (1) a reduction in lumen diameter of >50% or (2) a mean pressure gradient of >15 mm Hg. Technical success was assessed immediately after the procedure. The short-term results of stenosis were evaluated by serum creatinine (Scr) levels and blood pressure (BP). The long-term results were assessed by graft survival and renal function. From October 2009 to July 2015, a total of 660 patients had kidney transplantation and 22 cases underwent PI. The technical success was 100%. The mean Scr level preintervention was 321.6 ± 167.2 (range, 171.3-862.0) μmol/L, and it decreased to 145.3 ± 44.7 (range, 74.3-260.8) μmol/L 1 month postintervention (P < .001). Blood pressure was also improved at 1 month postintervention, as assessed by systolic (157.0 ± 13.0 vs 131.0 ± 11.0 mm Hg, P < .001), diastolic (95.0 ± 5.0 vs 77.0 ± 9.0 mm Hg, P < .001), and mean arterial pressure (116.0 ± 7.0 vs 95.0 ± 9.0 mm Hg, P < .001). The patency rate was 100%, 91.7%, and 85.7% at 1, 3, and 12 months, respectively. The secondary patency rate was 100%. Graft survival was 100% during follow-up. There was no significant deterioration in graft function or BP (P > .05) postintervention when compared to posttransplantation. Percutaneous intervention for TRAS is safe and results in significant improvement both in allograft function and in BP.