A Study on the Angioarchitecture of Hepatocellular Carcinoma

NCT03808766 | Terminated DMC

• 1 other identifier: VIR-18-09
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Hong Kong as well as globally. Transarterial therapy has been playing an important role in the treatment algorithm for patients with HCC. The primary purpose of transarterial therapy is eradication of the viability of the targeted tumors. The treatment outcomes have been variable among the various treatments, in general, there is still much room for improvement, especially for large size tumors. From the studies on Transarterial chemoembolization (TACE), it is known that the treatment outcome is affected by the nature and the formulation of therapeutic agents that are delivered, which is related to the angioarchitecture of the tumor. Knowledge on the angioarchitecture of HCC is essential for the understanding of the requirements for effective transarterial treatment of HCC. This prospective study is aimed to study the angioarchitecture of HCC.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• arterial flow through the tumor

  Digital subtraction angiography (DSA) is performed before and after embolization, through catheterization of the arterial branches supplying the tumor, images from arterial phase to delayed phase are captured. Contrast distribution at the arterial tumor branches, arterioles, tumor sinusoids, peri-tumoral liver, and peri-tumoral portal venules are observed.

  within one hour

Secondary Outcomes (1)

• The degree of tumor necrosis

  within 2 weeks after embolization

Study Arms (3)

Tumor <=3cm

OTHER

Embolization with particulate or liquid embolic agent

Other: embolization

Tumor >3cm to 7cm

OTHER

Embolization with particulate or liquid embolic agent

Other: embolization

Tumor > 7cm

OTHER

Embolization with particulate or liquid embolic agent

Other: embolization

Interventions

embolization OTHER

Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.

Tumor <=3cm; Tumor > 7cm; Tumor >3cm to 7cm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• HCC suitable for partial hepatectomy
• Child-Pugh A or B cirrhosis
• Eastern Cooperative Oncology Group performance score 0 or 1
• Barcelona clinic liver cancer (BCLC) staging A or B
• HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
• 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)

You may not qualify if:

• Previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
• Evidence of tumor invasion of portal vein or hepatic vein
• History of acute tumor rupture presenting with hemo-peritoneum
• Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
• Serum creatinine level \> 150umol/L

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Simon Yu

  DIIR, CUHK, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Tumors are categorized into 3 groups based on the longest diameter of the largest tumor: Group 1: ≤3cm Group 2: \>3cm to 7cm Group 3: \>7cm

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: January 18, 2019
• Study Start: August 13, 2018
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)