Clinical trial NCT03808766: A Study on the Angioarchitecture of Hepatocellular Carcinoma
Official title: A Study on the Angioarchitecture of 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: 2019-01-18
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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.

Detailed description: Embolization is performed within 2 weeks before the scheduled date of partial hepatectomy. The purpose of the timing is two folded, it allows observation of the embolization effect to be differentiated among the various embolic agents, it also allows time for the patient and the liver to recover from the embolization.

The patient then receives partial hepatectomy within 2 weeks unless the result of liver function tests shows contraindication to surgery, in which case the liver function test is further evaluated on a weekly basis until the findings are acceptable, and surgery is scheduled accordingly.

Eligibility criteria: Inclusion Criteria:

1. Age above 18 years
2. HCC suitable for partial hepatectomy
3. Child-Pugh A or B cirrhosis
4. Eastern Cooperative Oncology Group performance score 0 or 1
5. Barcelona clinic liver cancer (BCLC) staging A or B
6. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
7. 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)

Exclusion Criteria:

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

Primary outcomes:
measure: arterial flow through the tumor
timeFrame: within one hour
Secondary outcomes:
measure: The degree of tumor necrosis
timeFrame: within 2 weeks after embolization
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: