Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma: a Study on the Proof of Treatment Concept and Exploration of Selection Criteria for Clinical Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780802
• Other study ID #: VIR-20-13
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To prove the treatment concept of the use 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• The balloon catheter is placed at the various arterial feeders of the tumor
use of a balloon catheter for providing balloon occlusion, in addition to the standard microcatheter for drug delivery, both catheters are to be placed in parallel through a single guide catheter. Only one arterial puncture wound is involved. The inflated balloon provides temporary occlusion of all arterial tumor feeders except for the one which is selectively catheterized with a microcatheter for delivery of the therapeutic agent. The therapeutic agent consists of Lipiodol mixed with a chemotherapeutic drug, it is delivered through the microcatheter under fluoroscopic control.

Locations

Country	Name	City	State
Hong Kong	Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in hemodynamics of arterial blood supply to HCC tumors	The change in number of feeding arteries	immediately after completion of procedure
Primary	The change in the perfusion pattern of HCC tumors	The change in perfusion pressure.	immediately after completion of procedure
Secondary	Tumor response	Tumor response by CT such as complete response according to European Association for the Study of the Liver (EASL) necrosis guidelines.	3 months