A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®

This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives:

1. Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
2. Evaluate patient experience and toxicities associated with TheraSphere® treatment.
3. Measure tumor response rates

Study Overview

• Status: Completed
• Conditions: Neoplasms; Hepatocellular Carcinoma; Hepatoma; Liver Tumors
• Intervention / Treatment: Device: TheraSphere®

Detailed Description

The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from St. Joseph Hospital of Orange, community members in the St. Joseph Hospital service area and surrounding areas

Description

Inclusion Criteria:

• Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass with known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis)
• Surgical evaluation must conclude the patient is not a candidate for resection or ablation.
• ECOG Performance Status Score 0 - 2.
• Age 18 years or older.
• Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

Any pre-treatment laboratory findings within 15 days of treatment demonstrating:

• Absolute granulocyte count less than or equal to 1,500/ul
• Uncorrected Platelet count less than or equal to 75,000/ul
• Serum creatinine greater than or equal to 3.0 mg/dl
• Serum bilirubin greater than or equal to 2.0 mg/dl
• Any of the following contraindications to angiography and selective visceral catheterization, 1.)History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude catheterization.
• Portal hypertension with portal venous shunt away from the liver.
• Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere® administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.
• Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
• Significant extrahepatic disease representing an imminent life-threatening outcome.
• Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy).
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness.
• Pregnant women may not participate.
• Children may not participate due to lack of clinical experience.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients given access to treatment with TheraSphere.	The number of eligible patients provided with supervised access to treatment with TheraSphere with primary cancer to the liver who are not surgical resection candidates.	24 months
Evaluate patient experience with Therasphere.	Evaluation of patient experience and toxicities associated with Therasphere via patient follow-ups with clinician notes.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response to treatment with TheraSphere®	Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist.	24 Months

Collaborators and Investigators

• Sponsor: St. Joseph Hospital of Orange
• Investigators: Principal Investigator: Lawrence Wagman, M.D., F.A.C.S., St. Joseph Hospital of Orange

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 6, 2009
• First Posted (Estimate): April 7, 2009

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: HCC; Neoplasms; Liver cancer; Hepatoma; Liver tumors; Adult primary hepatocellular carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: 08-029 TheraSphere®