A Study to Evaluate Efficacy and Safety of TheraSphere and Resection Combination Therapy in Patients With Single Large ((> 5cm, Long Diameter ) Hepatocellular Carcinoma : Exploratory Trial

NCT05038397 | Completed

• 1 other identifier: BTG-SP-21.028-F01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate efficacy and safety of TheraSphere and resection combination therapy in patients with single large ((\> 5cm, long diameter ) hepatocellular carcinoma :

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival (RFS) after resection

  96 Weeks

Secondary Outcomes (4)

• Overall survival (OS) after resection

  96 Weeks

• Time to recurrence (TTR) of tumor after resection :

  96 Weeks

• Safety profiles

  96 Weeks

• Rate of post operative hepatic decompensation

  96 Weeks

Study Arms (1)

Therasphere

EXPERIMENTAL

Device: Theraspere

Interventions

Theraspere DEVICE

Prior to the administration of TheraSphere, the patient should undergo hepatic arterial catheterization using balloon catheterization or other appropriate angiographic techniques to prevent extrahepatic shunting. Following the placement of the hepatic catheter, 75 MBq to 150 MBq (2 mCi to 4 mCi) of Tc-99m MAA is administered into the hepatic artery to determine the extent of A-V shunting to the lungs and to confirm the absence of gastric and duodenal flow. When the possibility of extrahepatic shunting has been evaluated and the patient deemed acceptable for treatment, TheraSphere may be administered.

Therasphere

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent
• Clinical or histological diagnosis of HCC based on the guidelines of the American Association for the Study of Liver Diseases (AASLD).
• Single large (\> 5cm, long diameter) lesion that is typically enhanced\* and bi-dimensionally measurable by multiphasic spiral CT scan and dynamic contrast-enhanced MRI.
• Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) performed within 28 days prior to the enrollment
• Age of at least 19 years.
• ECOG Performance Status of 0.
• Child-Pugh class A (Child-Pugh score ≤6).
• Life expectancy of at least 16 weeks.
• Patients with bile duct involvement can be enrolled if patients have adequate bone marrow, liver, and renal function
• Adequate bone marrow, liver as assessed by the following laboratory requirements (no transfusion, no restoration), conducted screening: Data can be used within 28 days of screening.
• Hemoglobin ≥ 8.0g/dL
• Absolute neutrophil count (ANC) ≥ 1,000/mm3
• Platelet count ≥ 100,000/μL
• Total bilirubin ≤ 2mg/dL
• Serum albumin ≥ 3g/dL

You may not qualify if:

• Diffuse infiltrative tumor type
• Presence of separate daughter nodule
• Poorly defined and/or mixed-irregular tumor margin
• Definitive combined HCC-cholangiocarcinoma on images
• A history of receiving any systemic therapy of the molecularly targeted agents, immunotherapy, external beam radiation to the liver or cytotoxic chemotherapy for the treatment of HCC
• Presence of extrahepatic HCC: Involvement of vessels \[major branch of hepatic vein invasion; major branch of portal vein invasion from the first order portal vein branch (Vp3) to main portal vein (Vp4)\]; lymph node, metastasis
• History or presence of hepatic encephalopathy
• Ascites, moderate, large or intractable
• Active clinically serious infections (\> grade 2, NCI-CTCAE version 4.02), including spontaneous bacterial peritonitis.
• Untreated active chronic hepatitis B
• Esophageal or gastric varices ≥ F2 (grade 2) with red color sign positive without prophylaxis (non-selective beta-blocker or endoscopic variceal ligation) or history of variceal bleeding without endoscopic variceal ligation/ injection sclerosis
• Active ulcer of stomach or duodenum: untreated or presence of visible vessel
• Any major surgery within 4 weeks, or any minor surgery within 2 weeks prior to signing the informed consent form
• Candidate for liver transplantation and/or a history of liver transplantation
• History of cardiac diseases: congestive heart failure greater than NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); uncontrolled hypertension and diabetes mellitus

Sponsors & Collaborators

• MedicalExcellence: lead
• BTG International Inc.: collaborator
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: September 9, 2021
• Study Start: January 30, 2018
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-08

Locations

KR (1)