[c09aa8]: / clusters / 9knumclustersv2 / clust_2541.txt

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Patients must have an HCC diagnosis (initial, recurrent, progressive and/or refractory to other therapies) by at least one criterion listed below =< days prior to study entry\r\n* Pathologically (histologically or cytologically) proven diagnosis of HCC\r\n* At least one solid liver lesion or vascular tumor thrombosis (involving portal vein, inferior vena cava [IVC] and/or hepatic vein) > cm with arterial enhancement and delayed washout on multi-phasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis\r\n* For patients whose CURRENT disease is vascular only: enhancing vascular thrombosis (involving portal vein, IVC and/or hepatic vein) demonstrating early arterial enhancement and delayed washout on multi-phasic CT or MRI, in a patient with known HCC (diagnosed previously < days)
Absence of occlusive main portal vein thrombus, branch venous thrombus is allowed
Main portal vein tumor thrombosis
Thrombosis of the main portal vein
Main portal vein vascular invasion; for the dose escalation, segmental portal vein is allowed
Subjects must be considered poor prognosis by the following parameters: ) right or left portal vein involvement (NOTE: subjects with main portal vein involvement are excluded), ) multi-focal disease (more than tumors regardless of size) AND/OR ) diffuse disease considered amenable to liver directed therapy
Complete portal vein occlusion
Color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice
Occlusion of the main portal vein, or inadequate collateral flow around an occluded portal vein as determined by angiography
Main portal vein thrombosis (Vp) as documented on imaging
Patients with portal vein invasion
Patients with portal vein thrombus
Main portal vein tumor thrombus
Complete portal vein thrombosis on CT scans
Portal vein invasion at the main portal branch (Vp), inferior vena cava, or cardiac involvement of HCC based on imaging
There should be no macroscopic intravascular invasion of tumors into the main portal vein, hepatic vein, or vena cava.
Patients with extrahepatic disease, portal hypertension, or bilobar disease are allowed
Absence of occlusive thrombus in the main portal vein
Have portal or hepatic vein tumor invasion/thrombosis.
Patients with a history of gastrinoma, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting.
Portal vein occlusion
Complete occlusion of the main portal vein.
Ascites, or complete occlusion of main portal vein
Portal hypertension with portal venous shunt away from the liver
Portal hypertension with portal venous shunt away from the liver
Tumor thrombus involving main trunk of portal vein or inferior vena cava
Invasion of the main portal vein and/or tumor involvement in more than % of the liver (applicable only for the dose-escalation part)
No macroscopic intra-vascular invasion by tumors of the main portal vein, hepatic vein or vena cava.
Thrombotic or embolic event within the last months including portal vein thrombosis
ARM B: Patients must not have clinically significant ascites and/or portal vein thrombosis
Macrovascular tumor invasion of portal and/or hepatic vein(s)
Significant hepatic arterial to portal vein shunting in the area to be treated
No segmental, lobar or main portal vein thrombosis as evidence by cross sectional imaging
Splanchnic vein thrombosis (includes Budd-Chiari, portal vein, splenic and mesenteric thrombosis)
Portal vein invasion at the main portal (Vp), inferior vena cava, or cardiac involvement of HCC based on imaging.
Main portal vein thrombosis
Has portal vein invasion at the main portal (Vp), inferior vena cava, or cardiac involvement of HCC based on imaging
Portal vein invasion at the main portal branch (Vp)
No portal invasion or extrahepatic spread
Patients with occlusion of the main portal vein or of the right and left portal branches
Main portal vein thrombosis (PVT)
Occlusion of the main portal vein, or inadequate collateral flow around an occluded branch of the portal vein as determined by angiography
No portal invasion or extrahepatic spread on imaging.
Advanced tumoral disease (vascular invasion or extrahepatic spread, portal vein thrombosis of bland or malignant origin), or diffuse HCC, defined as % liver involvement).
Portal vein thrombosis of bland or malignant origin.
Macrovascular invasion of lobar portal vein branches or main portal vein.
Presence of main portal vein invasion by liver cancer
Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient)
Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
History of main or lobar portal vein thrombosis
Contraindications to hepatic artery embolization:\r\n* High risk of hepatic failure, indicated by the constellation of greater than % liver replacement by tumor, lactate dehydrogenase (LDH) > mU/ml, serum glutamic-oxaloacetic transaminase (SGOT)(aspartate aminotransferase [AST]) > mU/ml; and bilirubin > mg/dl\r\n* Portal vein occlusion without hepatopetal collateral flow demonstrated by angiography; or portal hypertension with hepatofugal flow\r\n* Hepatic encephalopathy
Occlusive main portal vein thrombosis
Main or segmental portal vein thrombosis
Clinically referred for portal vein embolization
Criteria , There is invasion by cancer into the main blood vessels such as the portal vein, hepatic vein or the vena cava