TACE Combined With ICIs Plus MTT After 125I Irradiation Stent Placement in HCC With Main PVTT.

According to the latest report, liver cancer is the third leading cause of cancer-related deaths, following lung and colorectal cancers, with hepatocellular carcinoma (HCC) accounting for 75% to 85% of all primary liver cancer cases. Portal vein tumor thrombosis (PVTT) is a significant indicator of poor prognosis in HCC, with a high incidence of 39-63% and a median survival of 2.7 months.

Systemic therapy is the recommended treatment for HCC patients with Vp4 \[main trunk\] portal vein tumor thrombus (PVTT). The landmark IMbrave150 study has ushered in a new era of combined systemic therapy for patients with unresectable HCC. However, subgroup analysis indicates that overall survival (OS) for HCC patients with Vp4 PVTT remains poor in both the sorafenib (5.5 months) or atezolizumab plus bevacizumab (7.6 months) groups.

Recent studies indicate that incorporating transcatheter arterial chemoembolization (TACE) significantly benefits HCC patients compared to systemic therapy alone, with significantly prolonged OS and progression free survival (PFS). However, HCC with PVTT is generally considered a contraindication to transcatheter arterial chemoembolization (TACE). When the portal vein blood supply has been damaged, TACE may lead to the reduction or even interruption of hepatic artery and the exacerbate the deterioration of liver function, eventually leading to liver failure. Although a few studies have explored TACE treatment in patients with Vp3-4 PVTT, the results have not shown a significant extension in survival.

Iodine-125 (125I) irradiation stent placement (ISP) can quickly restore blood flow and alleviate portal hypertension caused by tumor thrombus. Moreover, compared to bare stents, irradiation stents offer a uniform and sustained radiation distribution to PVTT, thus ensuring long-term patency of the portal vein and enabling the possibility of TACE for HCC patients with Vp4 PVTT. Our previous randomized controlled trial has demonstrated the safety and efficacy of ISP combined with TACE.

Herein, this nationwide multicenter, retrospective, propensity score matching (PSM) cohort study (PATENCYⅡ) aims to assess the safety and efficacy of immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) with or without ISP plus TACE as first line treatment for HCC patients with Vp4 PVTT.

• Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Срок оценки: up to approximately 2 years]
• PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) [Срок оценки: up to approximately 2 years]
• Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) per RESCIST 1.1 [Срок оценки: up to approximately 2 years]
• Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) per mRECIST [Срок оценки: up to approximately 2 years]
• Disease Control Rate (DCR) per RESCIST 1.1 [Срок оценки: up to approximately 2 years]
• Disease Control Rate (DCR) per mRECIST [Срок оценки: up to approximately 2 years]
• Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 [Срок оценки: up to approximately 2 years]
• Hepatic function [Срок оценки: up to approximately 2 years]
• Patency of portal vein [Срок оценки: up to approximately 2 years]