Clinical trial NCT04780802: Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in hemodynamics of arterial blood supply to HCC tumors
timeFrame: immediately after completion of procedure
measure: The change in the perfusion pattern of HCC tumors
timeFrame: immediately after completion of procedure
Secondary outcomes:
measure: Tumor response
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: DIIR, CUHK, Hong Kong
name: Simon Yu, Professor
role: PRINCIPAL_INVESTIGATOR
References: