Background Several previous studies demonstrated that the combination of self-expandable metallic stents (SEMS) and 125I seed implantation might prolong stent patency and obtain survival benefits for malignant obstructive jaundice (MOJ) patients. However, these studies rarely mentioned a comparison between CT-guided intratumoral 125I seed implantation and intraluminal 125I seed strand insertion combined with stenting for the management of MOJ. This study aimed to further evaluate the safety and efficacy of SEMS combined with 125I brachytherapy in the management of unresectable MOJ. Methods Fifty-nine patients with unresectable MOJ were retrospectively included from March 2018 to June 2021. The main therapeutic outcomes were evaluated in terms of stent patency, and overall survival. Cumulative stent patency and overall survival rates were calculated by Kaplan–Meier survival analysis. Both clinical and treatment factors associated with survival were analyzed. Results Technical success was achieved in all patients. The clinical success rate was 94% (32/34) in the seeds group and 92% (23/25) in the control group, no significant difference was found (p =1.000). The median duration of stent patency was significantly longer in the 125I brachytherapy group compared with the control group (289 days vs. 88 days, respectively, p =0.001). The 125I brachytherapy group demonstrated a significantly better median overall survival rate than the control group (221 days vs. 78 days, respectively, p =0.001). In multivariate analysis, stents with 125I brachytherapy (p =0.004) was a significant favorable prognostic factor that affected patient survival. No significant difference was observed between CT-guided 125I seed implantation and 125I seed strand insertion in stent patency (p =0.268), and overall survival (p =0.483). Conclusion SEMS combined with 125I brachytherapy is safe and effective for treating MOJ. 125I brachytherapy may help to maintain stent patency and prolong overall survival. There was no significant difference between CT-guided 125I seed implantation with SEMS and 125I seed strand insertion with SEMS in stent patency and overall survival.

Background This study aimed to evaluate the safety and efficacy of 125I brachytherapy combined with transarterial chemoembolization (TACE) and microwave ablation (MWA) for unresectable hepatocellular carcinoma (HCC) in high-risk locations. Patients and methods After 1:2 propensity score matching (PSM), this retrospectively study analyzed 49 patients who underwent TACE +MWA+125I brachytherapy (group A) and 98 patients who only received TACE +MWA (group B). The evaluated outcomes were progression-free survival (PFS), overall survival (OS), and treatment complications. Cox proportional hazards regression analysis survival was used to compare the two groups. Results The patients in group A showed a longer PFS than group B (7.9 vs. 3.3 months, P = 0.007). No significant differences were observed in median OS between the two groups (P = 0.928). The objective response rate (ORR), disease control rate of tumors in high-risk locations, and the ORR of intrahepatic tumors were 67.3%, 93.9%, and 51.0%, respectively, in group A, and 38.8%, 79.6% and 29.6%, respectively, in group B (P < 0.001, P = 0.025 and P = 0.011, respectively). TACE-MWA-125I (HR = 0.479, P < 0.001) was a significant favorable prognostic factor that affected PFS. The present of portal vein tumor thrombosis was an independent prognostic factor for PFS (HR = 1.625, P = 0.040). The Barcelona clinic liver cancer (BCLC) stage (BCLC C vs. B) was an independent factor affecting OS (HR = 1.941, P = 0.038). The incidence of complications was similar between the two groups, except that the incidence of abdominal pain was reduced in the group A (P = 0.007). Conclusions TACE-MWA-125I resulted in longer PFS and better tumor control than did TACE-MWA in patients with unresectable hepatocellular carcinoma in high-risk locations.

e16159 Background: Regorafenib and PD-1 inhibitor both are recommended as the standard second-line treatment for advanced hepatocellular carcinoma (HCC) in currently authorized guidelines. Local interventional therapies showed significant benefits in the treatment of HCC. We aimed to evaluate to investigate the efficacy and safety of regorafenib + PD-1 inhibitor combined with intervention therapy as the second-line treatment option for advanced HCC. Methods: From October 2019 to February 2022, 31 patients with advanced HCC treated with regorafenib+PD-1 were retrospectively included. All patients were divided into two groups: group A (n = 17, patients received regorafenib +PD-1 combined with local therapy), and group B (n = 14, patients received regorafenib+PD-1). The inclusion criteria are as follows: the first-line treatment was sorafenib or lenvatinib; advanced HCC (BCLC-C); ECOG score was 0-1; Child-Pugh score was 5-7; at least one measurable lesion; expected survival time ≥ 3 months. The treatment efficacy was evaluated by modified-RECIST. Objective response rate (ORR) and disease control rate (DCR) were evaluated in two groups. Major complications referred to those that result in death or serious adverse effects including sepsis, uncontrollable bleeding, and acute renal failure; others were considered minor complications. Results: The median follow-up time was 12.9 months. The median PFS was 8.3 months vs. 7.5 months (p = 0.814). The median TTP (Time to Progression) time was 8.3 months vs. 7.5 months (p = 0.973). In group A, eleven patients received TACE, 2 received thermal ablation, and 4 received HAIC. In group A: four patients reached PR (Partial response), and 7 patients stayed SD (Stable disease), while six patients suffered tumor progression (PD, Progression disease); In group B, only one patient reached PR, and 7 patients stayed SD, 6 patients suffered tumor progression. The ORR was 23.5% (group A) vs. 7.1% (group B), respectively. The DCR was 64.7% (group A) vs 57.1% (group B), respectively. The daily dose of Regorafenib was 80mg (58.8%), 120mg (29.4%), and 160mg (11.8%), respectively in group A. The daily dose of Regorafenib was 80mg (57.1%), 120mg (28.5%), and 160mg (14.3%), respectively in group B. The dose for the PD-1 inhibitor was 200mg (every three weeks). Adverse events of systemic drugs in group A and group B were 58.8% (10/17), and 35.7% (5/14), respectively. Hand–foot skin reaction was the most common adverse event in both groups (47.1% (8/17) vs 35.7% (4/140), respectively). No major complications of local therapies were observed in both groups. Conclusions: Regorafenib+PD-1 combined with local therapy as the second-line treatment option for advanced HCC may be effective and safe and provides better benefits than regorafenib+PD-1 alone.

e14620 Background: Hilar Cholangiocarcinoma (Klatskin tumor) is a rare and highly aggressive cancer that occurs at or near the junction of the right and left hepatic ducts. Gemcitabine + cisplatin has been established as an effective first-line treatment. However, this malignancy is commonly complicated by malignant biliary obstruction which may gradually damage patients’ liver function and may limit the chemotherapy. In addition, Cumulative clinical evidence showed that tyrosine kinase inhibitor (TKI) combined with immunotherapy is represented as a promising alternative. This study aimed to evaluate the clinical value of biliary intervention combined with the Lenvatinib+PD-1 inhibitor (Tislelizumab/Sintilimab) for the Klatskin tumor. Methods: From January 2020 to December 2022, 21 Klatskin tumor patients with malignant hilar biliary obstruction (MHBO) were included. All included patients received biliary decompression by metal stent + Iodine-125 seed strand (ISS) implantation. The number of 125I seeds to be implanted was determined according to the plan of the preoperative computerized treatment planning system (TPS). The procedure-related outcomes were evaluated regarding successful drainage and complications. In addition, the survival of patients who received successful biliary drainage and patients who received sequential systemic anticancer treatment were analyzed. Successful biliary drainage was defined as the serum total bilirubin level dropped by 75% of the preoperative value within 4 weeks. Major complications referred to those that result in death or serious adverse effects including sepsis, uncontrollable biliary or intestinal bleeding, and acute renal failure. The time between stent insertion and death was defined as patient survival. Results: 71.4% achieved successful drainage, significant improvements were observed from before to one month after the procedure in liver function values, including total bilirubin (TBIL), and direct bilirubin (DBIL) (all P<0.001). Minor complications occurred in 5 patients (23.8%) in all patients, including 1 patient (4.8%) who experienced cholangitis, and 4 patients (19%) who suffered abdominal pain. No major procedure-related complication was observed. The median overall survival(mOS) of 21 patients was 6.1 months. Patients who received successful biliary drainage (n=15) had longer mOS than those who received unsuccessful biliary drainage(n=6) [7.4 months vs. 3.5 months, respectively, P<0.001]. Patients who received sequential Lenvatinib+ Pembrolizumab after effective drainage(n=9) had longer mOS than those who only received palliative therapy(n=6) [7.4 months vs. 5.2 months, respectively, P=0.028]. Conclusions: Biliary intervention + ISS combined with the following Lenvatinib+ PD-1 inhibitor is safe and feasible for cholangiocarcinoma patients complicated with obstructive jaundice.

e14628 Background: Symptomatic portal hypertension (SPH) leads to a poor prognosis as a common complication in advanced hepatocellular carcinoma (HCC) patients due to cirrhosis or portal vein tumor thrombus. Although combined therapy including Lenvatinib and PD-1 inhibitors has shown valuable advantages in advanced HCC, the above strategy is limited by liver function impairment due to SPH complications such as variceal bleeding and refractory ascites. Transjugular intrahepatic portosystemic shunt (TIPS) directly relieves portal hypertension which may create a chance for advanced HCC patients with SPH to receive systemic therapy. Thus, TIPS plus following Lenvatinib and PD-1 inhibitor may serve as an effective anticancer modality. This study aimed to evaluate the efficacy and safety of TIPS combined with Lenvatinib and PD-1 inhibitor for advanced HCC patients with SPH. Methods: This retrospective study included thirteen advanced HCC with SPH patients who received TIPS combined with Lenvatinib and PD-1 inhibitor (Tislelizumab/Sintilimab) between January 2020 and January 2023. Main inclusion criteria: a confirmed HCC (BCLC stage C) based on the AASLD with either pathological or imaging findings; no previous systemic anticancer treatment; Child-Pugh score ≤10; ECOG status: 0-1. Portal hypertension with complications (variceal bleeding, refractory ascites). The outcome measures included objective response rate (ORR) (assessed with mRECIST v1.1), disease control rates (DCR), progression-free survival (PFS), overall survival (OS), SPH recurrence rate, and safety. Drug safety was investigated according to CTCAE (version 5.0). Results: With a median follow-up of 6.5 months (range 2.3-19.0), 13 patients with a median age of 57 years (range: 33-70) were evaluable for response and toxicity. 3 (23.1%) patients with Tislelizumab and 10 (76.9%) with Sintilimab. 7 (53.8%) patients were classified as Child-Pugh A class. According to mRECIST v1.1, ORR was 38.5% (95%CI, 11.8%-61.6%) with 1CR and 4 PR, and the DCR was 53.8% (95%CI, 21.3%-73.4%). The median overall survival (OS) was 16.5 months (95%CI,16.1-17.0). The prevalence of rebleeding, ascites and hepatic encephalopathy, was 7.7 %, 15.4%, and 7.7%, respectively. Treatment-related adverse events were confined to grades 1-2 occurring in 3/13 (23.1%) patients as rash (2, 15.4%) and fatigue (1, 7.7%). There were no treatment-related serious adverse events. Conclusions: TIPS combined with Lenvatinib and PD-1 inhibitor demonstrated a valuable anti-cancer strategy for advanced HCC patients with SPH based on the low recurrence rate of SPH and acceptable side effects.