Therapeutic Effect of Ethanol-gelfoam Mixture for the Treatment of Arterioportal Shunts (APS) in Patients With HCC

Nanjing Medical University

Status and phase: Unknown; Phase 3

Conditions: Carcinoma, Hepatocellular

Treatments: Procedure: TACE; Drug: EGM; Drug: PVA

Study type: Interventional

Funder types: Other

Identifiers

NCT02338297

HCC001

Details and patient eligibility

About

Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia.

Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC).

The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18
• Child-Pugh A or B cirrhosis
• ECOG performance status Grade 2 or below
• No serious concurrent medical illness
• No prior treatment (including surgery) for HCC
• Histologically or cytologically proven HCC (an alphafetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
• Unresectable and locally advanced disease without extra-hepatic disease
• Massive expansive or nodular tumor morphology with measurable lesion on CT
• Size of largest tumor <= 15cm in largest dimension
• Number of main tumor <= 5, excluding associated small satellite lesions
• Arterioportal shunts (APS) is found in the angiography of HCC blood supply

Exclusion criteria

• History of prior malignancy except skin cancer
• History of significant concurrent medical illness such as ischemic heart disease or heart failure
• History of acute tumor rupture
• Serum creatinine level > 180 umol/L
• Presence of biliary obstruction not amenable to percutaneous drainage
• Child-Pugh C cirrhosis
• History of hepatic encephalopathy, or
• Intractable ascites not controllable by medical therapy, or
• History of variceal bleeding within last 3 months, or
• Serum total bilirubin level > 50 umol/L, or
• Serum albumin level < 28g/L, or
• INR > 1.3
• Presence of extrahepatic metastasis
• Predominantly infiltrative lesion
• Diffuse tumor morphology with extensive lesions involving both lobes.
• Hepatic artery thrombosis, or
• Partial or complete thrombosis of the main portal vein, or
• Tumor invasion of portal branch of contralateral lobe, or
• Hepatic vein tumor thrombus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

TACE+EGM

Experimental group

Description:

Occlude APS with EGM and perform TACE sequentially

Treatment:

Drug: EGM

Procedure: TACE

TACE+PVA

Active Comparator group

Description:

Occlude APS with PVA and perform TACE sequentially

Treatment:

Drug: PVA

Procedure: TACE