ISP-TACE Versus TACE for HCC With PVTT

Study Overview
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Brief Summary
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For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients with HCC and PVTT.

Official Title
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Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Survival Benefit of Transarterial Chemoembolization in Combination With Irradiation Stent Placement

Conditions
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HCC, Portal Vein Tumor Thrombosis

Intervention / Treatment
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* Drug: ethiodized oil; doxorubicin;Gelfoam;
* Device: stent; idoine-125


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) newly diagnosed HCC with type II or III PVTT, (2) Child-Pugh classification grade A or B, (3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2. Exclusion Criteria: (1) type I or IV PVTT, (2) received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, (3) suffered from malignancy other than HCC, (4) with an incomplete data.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ISP-TACE group<br>During the study period, a total of 44 patients with HCC with PVTT underwent the irradiation stent placement and TACE were included in the ISP-TACE group. | Drug: ethiodized oil; doxorubicin;Gelfoam;<br>* Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles.<br>|
| TACE group<br>During the study period, a total of 82 patients with HCC with PVTT underwent TACE monotherapy were included in the ISP-TACE group. | Drug: ethiodized oil; doxorubicin;Gelfoam;<br>* Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles.<br>Device: stent; idoine-125<br>* In the ISP-TACE group, stent placement was performed one week before TACE. Under fluoroscopic and ultrasonic guidance, the outer stent was firstly placed at the site of the obstructed portal vein, and a self-expandable nitinol stent was immediately followed through a same 10-F sheath.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | The overall survival (OS) was defined as the time from first treatment to death or the patient's last follow up | 0-6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decompensation, tumor response, transarterial chemoembolization, stent, irradiation, survival