Clinical trial NCT02338297: Therapeutic Effect of Ethanol-gelfoam Mixture for the Treatment of Arterioportal Shunts (APS) in Patients With HCC
Official title: A Randomized Controlled Trial of Ethanol-gelfoam Mixture(EGM) Versus Gelfoam for the Treatment of Arterioportal Shunts (APS) in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolization (TACE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular Carcinoma
Arterioportal shunts
Transarterial Chemoembolization
Ethanol
Gelfoam
Polyvinyl Alcohol Foam Embolization Particles (PVA)
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 3 years
measure: APS improvement
timeFrame: 2 month
Secondary outcomes:
measure: Time To Progression
timeFrame: every 8 weeks, upto 3 years from date of randomization
measure: progression free survival
timeFrame: every 8 weeks, upto 3 years from date of randomization
measure: Response Rate
timeFrame: every 8 weeks, upto 3 years from date of randomization
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Zhong da hospital, Southeast university
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Haibin Shi, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: