Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients

Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients: Safety & Efficacy Registry in Taiwan (SUPER- Taiwan)

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order to provide clinical evidence in HCC management to physicians in the region, and to support the application of deTACE in treating advanced HCC patients.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma

Detailed Description

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order to provide clinical evidence on deTACE in HCC management to physicians in the region, and to support the application of in treating advanced HCC patients.

1. Primary Objective:

   To collect 1-year overall survival of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients in Taiwan.

2. Secondary Objectives:

   1. To evaluate the overall tumor response of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients. The tumor response is according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
   2. To evaluate the local tumor response (in the tumor(s) treated with drug-eluting microsphere) by chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.
   3. To evaluate the safety profile of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.

3. Exploratory Objectives:

   1. To evaluate the downstaging and downsizing potential of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients to within Milan Criteria and to within Resection margin.
   2. To collect time-to-progression (TTP) and progress-free-survival (PFS) data of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients.

Description

Inclusion Criteria:Patients must meet all of the following inclusion criteria in order to be entered into the study:

• Age 20 or older.
• Patient has signed informed consent.

• Patient must have a diagnosis of hepatocellular cancer confirmed by AASLD and at least one of the following method:

  • Magnetic resonance imaging (MRI) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm.
  • Contrast enhanced computed tomography (CT) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm.
  • Histological confirmation is required for lesions with inconclusive features.

• Patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.

  • Patients not suitable for ablation due to lesion location may be enrolled.
  • Patients with HCC recurrence but not suitable for resection or ablation maybe enrolled.

• Patient MUST be with either BCLC stage B OR C, and meet the following criteria:

  • Stage Child-Pugh A or B AND
  • Performance status ECOG ≤ 1 WITH Vascular Invasion or WITHOUT Vascular invasion.
• Patient has a life expectancy of at least 6 months.

Exclusion Criteria:If patients meet any of the following criteria they may not be entered into the study:

• Current or previous treatment with chemo- or radiation therapy or sorafenib or drug-eluting chemoembolization (deTACE).
• Patients with concurrent cancer except non-melanomatous skin cancer.
• Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive.
• Performance status ECOG > 1.
• Child-Pugh Class C.
• Occlusive tumor thrombus to the main portal trunk.
• Active gastrointestinal bleeding.
• Evidence of uncorrectable bleeding diathesis.
• Extra-Hepatic spread of the HCC.
• Encephalopathy not adequately controlled medically.
• Presence of ascites not controlled medically.
• Any contraindication for MRI/ CT (eg. metallic implants).
• Allergy to contrast media that cannot be managed with prophylaxis.
• Any contraindication to arteriography.
• Any contraindication for doxorubicin administration.
• Any contraindication for hepatic embolization. Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization. Hepatofugal blood flow. Serum creatinine > 2mg/dL. Other condition deemed exclusionary by physician. Uncorrectable impaired clotting.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	To define all participants from the day of the first HepaSphere Treatment until end of study or death is reported, whichever comes first.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response	Tumor response will be assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria to evaluate tumor necrosis under CT/ MRI and will be presented as %.	1 year
Adverse Event (AE)	Adverse event will be accessed according to CTCAE 4.0 after treatments until end of study or death.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Objectives, Time-To-Progression (TTP)	To define all participants from the day of the first HepaSphere Treatment until tumor progression or death is first reported, whichever comes first.	1 year
Exploratory Objectives, Downstaging	Tumor staging will be accessed according to BCLC staging system and Milan criteria, and will be reviewed at follow-up until end of study or death.	1 year

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Taiwan University Hospital; China Medical University Hospital; Chang Gung Memorial Hospital; Tri-Service General Hospital
• Investigators: Principal Investigator: Yi-Hsiang Huang, M.D. Ph.D., Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2016
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Unresectable; Advanced HCC; deTACE; HepaSphere
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: HEPA-Taiwan-001