Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    30
  • sponsor
    Chinese University of Hong Kong
Updated on 16 August 2021
measurable disease

Summary

To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC and to explore the selection criteria for clinical application of balloon assistance in transarterial therapy for HCC.

Description

Transcatheter arterial chemoembolization (TACE) has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions of hepatocellular carcinoma (HCC) not eligible for surgical resection, transplantation, or local ablative therapy. The use of balloon assisted TACE has been proposed recently and it could be one of the possible ways to improve the effectiveness of drug delivery to the target tumor and therefore leading to improved treatment outcome.

Details
Condition liver cell carcinoma, Liver Cancer, Adenocarcinoma, Malignant Adenoma, HEPATOCELLULAR CARCINOMA, HEPATIC NEOPLASM
Treatment The balloon catheter is placed at the various arterial feeders of the tumor
Clinical Study IdentifierNCT04780802
SponsorChinese University of Hong Kong
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients of age above 18 years
Patients who are indicated for transarterial treatment for HCC
Child-Pugh A or B cirrhosis
Eastern Cooperative Oncology Group performance score 0 or 1
BCLC A or B
No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy)
HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen
No invasion of portal vein or hepatic vein
Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)
Total tumor mass < 50% liver volume
Size of any individual tumor <= 7cm in largest dimension
Serum creatinine < 130 umol/L or Creatinine clearance > 55 ml/min

Exclusion Criteria

Concurrent ischemic heart disease or heart failure
History of asthma, chronic obstructive airway disease or respiratory decompensation
History of acute tumor rupture presenting with hemo-peritoneum
Biliary obstruction not amenable to percutaneous or endoscopic drainage
Child-Pugh C cirrhosis
History of hepatic encephalopathy
Intractable ascites not controllable by medical therapy
History of variceal bleeding within last 3 months
Serum total bilirubin level > 50 umol/L
Serum albumin level < 26 g/L
INR > 1.3
Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
Arterio-portal venous shunt affecting >1 hepatic segment on CT
Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
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