Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

The Chinese University of Hong Kong

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: The balloon catheter is placed at the various arterial feeders of the tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT04780802

VIR-20-13

Details and patient eligibility

About

To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients of age above 18 years
2. Patients who are indicated for transarterial treatment for HCC
3. Child-Pugh A or B cirrhosis
4. Eastern Cooperative Oncology Group performance score 0 or 1
5. BCLC A or B
6. No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
7. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
8. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
9. No invasion of portal vein or hepatic vein
10. 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)
11. Total tumor mass < 50% liver volume
12. Size of any individual tumor <= 7cm in largest dimension
13. Serum creatinine < 130 umol/L or Creatinine clearance > 55 ml/min.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ballloon catheter

Other group

Description:

Balloon-assisted transarterial therapy will be performed in the first treatment session only

Treatment:

Procedure: The balloon catheter is placed at the various arterial feeders of the tumor