Hepatocellular Carcinoma
Conditions
Keywords
Unresectable HCC
Brief summary
MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can have placement of appropriately positioned hepatic arterial catheters. Outcomes of this treatment protocol will be monitored and reported to the Carolinas HealthCare System Institutional Review Board.
Detailed description
The objectives of this study are to provide supervised access to treatment with TheraSphere to eligible patients with Hepatocellular Carcinoma of the liver who are not surgical resection candidates and to evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment. This is an observational treatment use protocol that will provide Institutional Review Board (IRB) oversight and documentation of the clinical experience of patients undergoing treatment for liver carcinoma using TheraSphere. Participation involves no investigational or research procedures. Patients will be followed for treatment-related adverse experiences and will be monitored in accordance with institutional practices. Approximately 60 patients will be enrolled in a treatment protocol and the number may be expanded following completion of the first cohort. The total number of patients to be treated will be determined based on clinical experience and patient outcomes. There are no control subjects in this treatment protocol. The duration of the protocol will depend on patient experience with this treatment. An initial one year approval is sought at this time. Patient experience will be evaluated continuously and if the clinicians find that the treatment provides benefits to patients, renewal of the approval will be sought after the first 12 months.
Interventions
RADIATIONTheraSphere-Yttrium 90 microsphere
TheraSphere is delivered to the liver via a catheter placed into the femoral artery and guided by fluoroscopy to the hepatic artery. Once the catheter is properly positioned, the physician infuses TheraSphere, which localizes preferentially in the tumor.
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of intrahepatic carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha feta protein (AFP) markers (clinical diagnosis). * The cancer must be unresectable. * Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2 * Age greater than or equal to 18 * Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
Exclusion criteria
* Any pre-treatment lab findings within 15 days of treatment demonstrating: absolute granulocyte count less than or equal to 1,500/ul, platelet count less than or equal to 45,000/ul, serum creatinine greater than or equal to 3.0 mg/dl, serum bilirubin greater than or equal to 4.0 mg/dl * Any of the following contraindications to angiography and selective visceral catheterization: history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine; bleeding diathesis, not correctable by usual forms of therapy; 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 milliCurie (mCi) or 30 gray (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 microaggregate albumin (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 or pulmonary insufficiency * Active uncontrolled infection * Significant underlying medical or psychiatric illness. * Pregnant women may not participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression | 6 months | Progression of liver cancer |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Unacceptable Side Effects After Treatment | 6 months |
Participant flow
Recruitment details
Total number of patients treated with TheraSphere was 11.
Pre-assignment details
Candidates were selected by the physicians for treatment with TheraSphere, patient's signed informed consent and were treated if they met the criteria for treatment using the Humanitarian Device Exemption (HDE) protocol.
Participants by arm
| Arm | Count |
|---|---|
| TheraSphere Treatment Total number of patients enrolled, TheraSphere treatment | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | TheraSphere Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 60.2 years STANDARD_DEVIATION 8.509 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Progression
Progression of liver cancer
Time frame: 6 months
Population: Number of participants enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TheraSphere Treatment | Progression | 11 participants |
Secondary
Number of Participants With Unacceptable Side Effects After Treatment
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TheraSphere Treatment | Number of Participants With Unacceptable Side Effects After Treatment | 0 Participants |