Carcinoma, Hepatocellular, Hepatoma
Conditions
Keywords
unresectable hepatocellular carcinoma, HCC, SIR-Spheres, Y-90 Microspheres, brachytherapy, Selective Internal Radiation Therapy (SIRT), liver cancer
Brief summary
The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.
Detailed description
This study is a multi-institutional, non-randomized pilot study that aims to assess the safety and toxicity of hepatic arterial radioembolization using SIR-Spheres yttrium-90 microspheres (SIR-Spheres microspheres) in the treatment of patients with unresectable primary hepatocellular carcinoma (HCC). The study aims to recruit 40 patients over a period of 24 months.
Interventions
DEVICESIR-Spheres microspheres
SIR-Spheres Yttrium-90 microspheres
Sponsors
Sirtex Medical
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
* must have a confirmed diagnosis of HCC. * at least 18 years of age. * must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 International Units/milliliter (UI/ml). * must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis. * must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI). * must present with a whole-liver tumor burden of greater than or equal to 15% and less than or equal to 70% * must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. * must have normal organ and marrow function
Exclusion criteria
Includes both the listed contraindications to SIR-Spheres® and the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events Grade 3 or Higher | From date of enrollment until the date of death from any cause assessed up 24 weeks. | Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks. | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Tumor Response Rate | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks. | Tumour response rates estimated by the proportion of patients with a best response of CR, PR or SD by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) with corresponding exact 90% confidence limits being reported. Per RECIST v1.0 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Change From Baseline in Health-related Quality of Life | 52 weeks | — |
| Overall Survival | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks. | Overall Survival is defined as the time interval between the date of enrollment and the date of death from any cause. |
Countries
United States
Participant flow
Recruitment details
Three medical centers in the US enrolled 10 patients from July 18, 2007 to March 9, 2010.
Participants by arm
| Arm | Count |
|---|---|
| Hepatic Arterial Radioembolization SIR-Spheres Microspheres SIR-Spheres microspheres
SIR-Spheres microspheres: SIR-Spheres Yttrium-90 microspheres | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Hepatic Arterial Radioembolization SIR-Spheres Microspheres |
|---|---|
| Age, Continuous | 68.0 years |
| Disease characteristics Cirrhosis (No) | 2 Participants |
| Disease characteristics Cirrhosis (Yes) | 8 Participants |
| Disease characteristics CLIP score Class 1 | 4 Participants |
| Disease characteristics CLIP score Class 2 | 2 Participants |
| Disease characteristics CLIP score Class Unknown | 4 Participants |
| Disease characteristics Hepatitis B (No) | 9 Participants |
| Disease characteristics Hepatitis B (Yes) | 1 Participants |
| Disease characteristics Hepatitis C (No) | 7 Participants |
| Disease characteristics Hepatitis C (Yes) | 3 Participants |
| Disease characteristics History of alcohol abuse (No) | 7 Participants |
| Disease characteristics History of alcohol abuse (Yes) | 3 Participants |
| Disease characteristics Metabolic Liver Disease (No) | 10 Participants |
| Disease characteristics Okuda Stage 1 | 10 Participants |
| Disease characteristics TNM Classification of Primary Tumor, T2 | 2 Participants |
| Disease characteristics TNM Classification of Primary Tumor, T3 | 6 Participants |
| Disease characteristics TNM Classification of Primary Tumor, T4 | 2 Participants |
| Disease characteristics TNM Classification of regional lymph nodes (No) | 10 Participants |
| ECOG performance status 0 (full activity) | 8 Participants |
| ECOG performance status 1 (ambulatory restricted) | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Previous chemotherapy No | 9 Participants |
| Previous chemotherapy Yes | 1 Participants |
| Previous radiotherapy No | 9 Participants |
| Previous radiotherapy Yes | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 3 / 10 |
Outcome results
Primary
Number of Participants With Adverse Events Grade 3 or Higher
Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.
Time frame: From date of enrollment until the date of death from any cause assessed up 24 weeks.
Population: Safety population - all patients who received initial SIRT treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SIR-Spheres Microspheres | Number of Participants With Adverse Events Grade 3 or Higher | 3 Participants |
Secondary
Change From Baseline in Health-related Quality of Life
Time frame: 52 weeks
Population: This outcome measure was not assessed as no data was collected prior to termination of the study.
Secondary
Overall Survival
Overall Survival is defined as the time interval between the date of enrollment and the date of death from any cause.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Population: This outcome measure was not assessed as no data was collected prior to termination of the study.
Secondary
Time to Disease Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Population: This outcome measure was not assessed as no data was collected prior to termination of the study.
Secondary
Tumor Response Rate
Tumour response rates estimated by the proportion of patients with a best response of CR, PR or SD by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) with corresponding exact 90% confidence limits being reported. Per RECIST v1.0 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Population: This outcome measure was not assessed as no data was collected prior to termination of the study.