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

Carcinoma, Hepatocellular Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02338297
• Other study ID #: HCC001
• Status: Recruiting
• Phase: Phase 3
• First received: December 18, 2014
• Last updated: March 31, 2016
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Nanjing Medical University
• Contact: Haibin Shi, MD, PhD.
• Phone: 086-025 681 369 18
• Email: shihb[@]njmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Procedure:
• TACE
Transarterial chemoembolisation (TACE)

Drug:
• EGM
Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)
• PVA
Occlude arterioportal shunts(APS) with PVA

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Zhong da hospital, Southeast university	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	Defined as time (in days) from time of TACE non-eligibility to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period, respectively. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.	3 years	No
Primary	APS improvement	Changes of Arterioportal Shunts Treated with PVA or EGM	2 month	No
Secondary	Time To Progression	Time from randomization to radiological progression. Definition of progression is based on the mRECIST criteria. Deaths during follow-up without evidence of radiological progression are censored.	every 8 weeks, upto 3 years from date of randomization	No
Secondary	progression free survival	Time from randomization to either radiological progression or death. Patients alive and free of progression at the end of follow-up are censored.	every 8 weeks, upto 3 years from date of randomization	No
Secondary	Response Rate	Definition of response is based on the mRECIST criteria.	every 8 weeks, upto 3 years from date of randomization	No