Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

• ClinicalTrials.gov Identifier: NCT03662841
• Recruitment Status: Recruiting
• First Posted: September 10, 2018
• Last Update Posted: March 4, 2021
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Simon Yu, Chinese University of Hong Kong

Tracking Information

• First Submitted Date: September 6, 2018
• First Posted Date: September 10, 2018
• Last Update Posted Date: March 4, 2021
• Actual Study Start Date: July 13, 2018
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2018)

Time to progression [ Time Frame: 3 to 6 months after treatment ]

the interval between the first treatment date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2018)

Tumor response [ Time Frame: 3 to 6 months after treatment ]

Tumor response at 3 month and 6 month from the date of first treatment as evaluated by triphasic contrast enhanced CT according to the EASL criteria

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
• Official Title: Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Use of ACE for HCC of size > 10cm

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Carcinoma, Hepatocellular

Intervention

Procedure: Ablative chemoembolization (ACE)

Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin

Study Arms

ACE for HCC of size >10cm

Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin

Intervention: Procedure: Ablative chemoembolization (ACE)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 19, 2019): 35
• Original Estimated Enrollment (submitted: September 6, 2018): 30
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Carmen Wong; (852) 3505 3210; carmenwongsp@cuhk.edu.hk

Contact: Pui Man Chong; (852) 3505 4094; siuman@cuhk.edu.hk

• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT03662841
• Other Study ID Numbers: VIR-18-08
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Simon Yu, Chinese University of Hong Kong
• Study Sponsor: Chinese University of Hong Kong
• Collaborators: Not Provided

Investigators

• Principal Investigator: Simon Yu; DIIR, CUHK, Hong Kong

• PRS Account: Chinese University of Hong Kong
• Verification Date: February 2021