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

NCT02338297 | Unknown Phase 3 DMC

• 1 other identifier: HCC001
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 2

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular Carcinoma; Arterioportal shunts; Transarterial Chemoembolization; Ethanol; Gelfoam; Polyvinyl Alcohol Foam Embolization Particles (PVA)

Outcome Measures

Primary Outcomes (2)

• 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

• APS improvement

  Changes of Arterioportal Shunts Treated with PVA or EGM

  2 month

Secondary Outcomes (3)

• Time To Progression

  every 8 weeks, upto 3 years from date of randomization

• progression free survival

  every 8 weeks, upto 3 years from date of randomization

• Response Rate

  every 8 weeks, upto 3 years from date of randomization

Study Arms (2)

TACE+EGM

EXPERIMENTAL

Occlude APS with EGM and perform TACE sequentially

Procedure: TACE; Drug: EGM

TACE+PVA

ACTIVE COMPARATOR

Occlude APS with PVA and perform TACE sequentially

Procedure: TACE; Drug: PVA

Interventions

TACE PROCEDURE

Transarterial chemoembolisation (TACE)

TACE+EGM; TACE+PVA

EGM DRUG

Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)

TACE+EGM

PVA DRUG

Occlude arterioportal shunts(APS) with PVA

TACE+PVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (2)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

Zhong da hospital, Southeast university

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Haibin Shi, MD, PhD.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haibin Shi, MD, PhD.

CONTACT

086-025 681 369 18; shihb@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiology Department, the First Affiliated Hospital of Nanjing Medical University

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 14, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 1, 2016

Record last verified: 2015-11

Locations

CN (2)