An observational study in Hepatocellular Carcinoma, sponsored by Zhongda Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Zhongda Hospital · Observational
Hepatocellular carcinoma (HCC) patients with Vp4 [main trunk] portal vein tumor thrombosis (PVTT) face a significantly poor prognosis, and current treatment options provide limited benefits. We aimed to assess the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) after irradiation stent placement (ISP) as first line treatment for HCC patients with Vp4 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.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's planned enrollment of 444 is above the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Zhongda Hospital is the lead sponsor of 103 studies on the registry; 41 are open to participants now.
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Patients with HCC and Vp4 PVTT who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies after 125I irradiation stent placement under real-world practice conditions
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Exclusion Criteria:
Overall Survival (OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Time frame: Up to approximately 2 years
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.
Time frame: up to approximately 2 years
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Time frame: up to approximately 2 years
Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) per RESCIST 1.1
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Time frame: up to approximately 2 years
Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) per mRECIST
The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Time frame: up to approximately 2 years
Disease Control Rate (DCR) per RESCIST 1.1
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.
Time frame: up to approximately 2 years
Disease Control Rate (DCR) per mRECIST
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.
Time frame: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Time frame: up to approximately 2 years
Hepatic function
Hepatic function was measured in terms of total bilirubin, albumin, aspartate transaminase, alanine aminotransferase, alkaline phosphatase, prothrombin time
Time frame: up to approximately 2 years
Patency of portal vein
Patency of portal vein was evaluated by color doppler ultrasound
Time frame: up to approximately 2 years
Started Jan 2024 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.
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