Clinical trial NCT03662841: Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
Official title: Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Use of ACE for HCC of size \> 10cm
Primary purpose: TREATMENT

Brief summary: The objective of this study is to study the safety and tumor response of ACE for large HCC.

Detailed description: Transarterial treatment has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic hepatocellular carcinoma not eligible for surgical resection, transplantation, or local ablative therapy. Among the patient group with intermediate tumor stage, in which the tumor dimension exceeds 10cm, the treatment outcome of conventional chemoembolization (cTACE), chemoembolization using drug eluting beads (DEB-TACE) and radioembolization using yttrium 90 is generally unsatisfactory. Some would consider HCC of size \>10cm a relative contraindication for cTACE because of the poor treatment outcome. However, there is no better alternative treatment for local control of these tumors. Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin has been found to be highly effective for local control of HCC as compared to cTACE in a case-control study. It is hypothesized that ACE is safe and effective for local control of large HCC of size \>10cm.

Eligibility criteria: Inclusion Criteria:

1. Signage of a written informed consent
2. Age above 18 years
3. HCC unsuitable for resection
4. Child-Pugh A or B cirrhosis
5. Eastern Cooperative Oncology Group performance score 0 or 1
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 \>10cm in largest dimension

Exclusion Criteria:

1. History of acute tumor rupture presenting with hemo-peritoneum
2. Biliary obstruction not amenable to percutaneous or endoscopic drainage
3. Child-Pugh C cirrhosis
4. History of hepatic encephalopathy
5. Intractable ascites not controllable by medical therapy
6. History of variceal bleeding within last 3 months
7. Serum total bilirubin level \> 50 umol/L
8. Serum albumin level \< 25g/L
9. INR \> 1.7
10. Serum creatinine level \> 150 mmol/L.
11. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
12. Arterio-portal venous shunt affecting \>1 hepatic segment on CT
13. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT

Primary outcomes:
measure: Time to progression
timeFrame: 3 to 6 months after treatment
Secondary outcomes:
measure: Tumor response
timeFrame: 3 to 6 months after treatment
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
role: PRINCIPAL_INVESTIGATOR
References: