Hepatocellular Carcinoma (HCC)
Conditions
Keywords
Hepatocellular Carcinoma (HCC), Trans-Arterial Chemobolizaion (TACE), Radiation Induced Liver Disease (RILD), Stereotactic Body Radiation Therapy (SBRT)
Brief summary
This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.
Detailed description
Primary objectives of this research 1. Evaluate the safety of a combination of TACE and high dose SBRT 2. Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE & SBRT. Secondary objectives of this research 1. Assess failure patterns and survival of patients treated with TACE & SBRT. 2. Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.
Interventions
COMBINATION_PRODUCTStereotactic Body Radiation Therapy (SBRT)
This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis Patients meeting all the following criteria will be considered for enrollment: * Pathologically confirmed HCC -OR * HCC greater than 2 cm with classic radiographic findings on 2 separate testing modalities, or an HCC greater than 2 cm with a serum alpha feto-protein greater than 200. Lesions: Single liver lesion: measuring 3 cm to ≤ 8 cm\*. * Multiple liver lesions: ≤ 3 liver lesions, none measuring over 5 cm, provided all lesions are considered for TACE. * Lesions \<3 cm if they are in an unfavorable location for ablation† \*The size criteria of hepatic lesions are also subjected to the dose volume constraints for radiotherapy, as described below. Patient * Patient deemed to not candidate or should have refused liver-transplant, surgery or RFA. * Patient must be a candidate and receive TACE. * ECOG (Eastern Cooperative Oncology Group) Zubrod Performance Scale = 0-1. * Age \> 19 * Patient should not be pregnant. Women of childbearing potential and male participants must practice adequate contraception. Adequate hematological profile and adequate liver functions. Signed informed consent document Imaging studies completed at least 60 days prior to study entry. Evaluated by radiation oncologist within 2 weeks prior to study entry.
Exclusion criteria
Patients presenting with any of the following will not be included in the study: 1. Prior invasive malignancies 2. Prior radiotherapy to the liver or surrounding areas. 3. Systemic therapy using any chemotherapy and/or targeted agents given within 2 weeks prior to TACE, during RT, and / or within 3 weeks following RT 4. Severe medical co-morbidities 5. INR (international normalized ratio) \> 2 times upper level normal 6. Uncontrolled or symptomatic clinical ascites 7. Major surgical procedure within 3 weeks prior to study entry. 8. History of hypersensitivity to chemotherapy agents, contrast material. 9. Pregnancy, breast-feeding or planning to become pregnant. 10. Treatment with any investigational product in the last 4 weeks before study entry. 11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Patients of Reproductive Potential The patient must not be pregnant or breast-feeding at enrollment in the study. Absence of pregnancy must be demonstrated by serum or urine testing prior to enrollment into the study. Female patients of child bearing potential (i.e., ovulating, premenopausal, not surgical sterile) must use a medically accepted contraceptive regimen. Male patients must agree to use a medically approved method of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of a Combination Therapy | Baseline to 45 day after completing combination treatment. | Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred. |
| Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT. | Baseline to up to 2 years after treatment completed | Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment. |
| Local Recurrence Rate | Baseline to up to 2 years after treatment completed | Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Overall Survival | up to 2 years after treatment completed | Assess overall survival (OS) of patients treated with TACE & SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive. |
| Percentage of Participants With Local Failure Patterns | Baseline up to 2 years after treatment completed | Assess local failure patterns of patients treated with TACE & SBRT. This is assessed by the percentage of patients where recurrence occurred |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TACE + SBRT Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy.
Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | TACE + SBRT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 11 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Local Recurrence Rate
Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.
Time frame: Baseline to up to 2 years after treatment completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACE + SBRT | Local Recurrence Rate | 7 participants |
Primary
Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.
Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.
Time frame: Baseline to up to 2 years after treatment completed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TACE + SBRT | Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT. | 25.6 months |
Primary
Safety of a Combination Therapy
Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.
Time frame: Baseline to 45 day after completing combination treatment.
Population: All enrolled patients were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACE + SBRT | Safety of a Combination Therapy | 0 participants |
Secondary
Percentage of Participants With Local Failure Patterns
Assess local failure patterns of patients treated with TACE & SBRT. This is assessed by the percentage of patients where recurrence occurred
Time frame: Baseline up to 2 years after treatment completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACE + SBRT | Percentage of Participants With Local Failure Patterns | 41.2 percentage of participants |
Secondary
Percentage of Participants With Overall Survival
Assess overall survival (OS) of patients treated with TACE & SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.
Time frame: up to 2 years after treatment completed
Population: Survival analysis was performed for all patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACE + SBRT | Percentage of Participants With Overall Survival | 82.3 percentage of participants |