Hepatocellular Carcinoma
Conditions
Brief summary
This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).
Interventions
DEVICESelective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)
Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria. * The cancer is unresectable. * All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Age 18 years or older. * Able to understand informed consent.
Exclusion criteria
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: * single TheraSphere administration; or * cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments. * Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow. * Previous radiation therapy to the lungs and/or to the upper abdomen * Pregnancy * Symptomatic lung disease. * Significant extrahepatic disease representing an imminent life-threatening outcome. * Active uncontrolled infection * Any pre-treatment laboratory findings within 30 days of treatment demonstrating: * Aspartate or alanine aminotransferase level greater than 5 times upper normal limit. * Serum bilirubin greater than 2 mg/dl * Infiltrative tumor on imaging * Tumor volume greater than 70% of liver volume * Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 6 months | Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 6 months | Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT: up to 5 lesions at baseline and sum longest diameters (SLD). * Complete Response (CR), -Target Lesions: Disappearance of all target lesions. -Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level. * Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; * Stable Disease (SD) \< %30 decrease in the sum of the longest diameter of target lesions. * Progressive Disease (PD) -Target Lesions: \> 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy |
Countries
United States
Participant flow
Recruitment details
Yttrium-90 radioembolization there were 14 total patients who signed consent and participated in the study. Enrollment started in May2010 and ended in June 2013.
Pre-assignment details
A 2nd radioembolization treatment was allowed if patients had bilobar tumors and were willing to get repeated treatments.
Participants by arm
| Arm | Count |
|---|---|
| Yttrium-90 Liver Radioembolization Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
Baseline characteristics
| Characteristic | Yttrium-90 Liver Radioembolization |
|---|---|
| Age, Continuous | 66 years |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Number of Participants With Adverse Events
Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Yttrium-90 Liver Radioembolization | Number of Participants With Adverse Events | 3 participants |
Secondary
Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT: up to 5 lesions at baseline and sum longest diameters (SLD). * Complete Response (CR), -Target Lesions: Disappearance of all target lesions. -Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level. * Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; * Stable Disease (SD) \< %30 decrease in the sum of the longest diameter of target lesions. * Progressive Disease (PD) -Target Lesions: \> 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Yttrium-90 Liver Radioembolization | Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Stable Disease (SD) | 8 Participants |
| Yttrium-90 Liver Radioembolization | Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Complete Response (CR) | 0 Participants |
| Yttrium-90 Liver Radioembolization | Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Partial Response (CR) | 5 Participants |
| Yttrium-90 Liver Radioembolization | Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Progressive Disease (PD) | 1 Participants |