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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
H220001 / PAS001 |
| Date Original Protocol Accepted |
07/17/2024
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| Date Current Protocol Accepted |
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| Study Name |
The TheraBionic P1 Post-Approval Study
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| Device Name |
TheraBionic P1
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| Clinical Trial Number(s) |
NCT00534664 NCT04327700
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Non-Randomized, Single-Arm Uncontrolled Study to assess Overall Survival using the TheraBionic P1 system for patients with advanced hepatocellular carcinoma (HCC) who have failed two lines of therapy.
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| Study Population |
Patients with advanced hepatocellular carcinoma (HCC, defined as a liver tumor not eligible for local therapies given the extent of disease or a liver tumor that recurred after local therapy) who have failed at least two lines of therapy or who that are no longer eligible for any line of standard therapy.
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| Sample Size |
Number of subjects: 178 (198 considering 10% attrition rate)
Number of sites: 3
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| Key Study Endpoints |
Primary Endpoint:
Overall survival will be assessed from the day of TheraBionic
treatment initiation until death, or up to 24 months post the start of
treatment.
Secondary Endpoints:
- Patient-reported outcome will be recorded once a week for the first three weeks (3 measurements), then every other week for the next six weeks (3 measurements), then every month afterwards, after the subject starts treatment. The PROs will be administered electronically and/or remotely.
- The frequency and nature of patient-reported symptomatic serious adverse device events will be assessed using 10 items from the PROCTCAE item library assessed at every return visit recorded once a week for the first three weeks (3 measurements), then every other week for the next six weeks (3 measurements), then every month afterwards, after the subject starts treatment and at the end of treatment.
- Patient-rated pain intensity will be measured using scores from the single item PROMIS Numeric Pain Rating Scale (Pain Intensity 1a) patient-reported outcomes (PRO)
- Pain interference will be measured using scores from the Pain Interference Short Form 4a PRO
- ECOG Performance Status Scale to measure functional status and ability to carry out activities of daily living.
- Overall response rate (ORR) based on physician evaluation
- Disease control rate (DCR) based on physician evaluation
- Duration of overall response that is measured from CR/PR until the first date of documented recurrent or progressive disease
- Duration of overall complete response that is measured from CR until the first date of documented recurrent or progressive disease
- Duration of stable disease
- Time to radiological progression (TTP)
- Progression-free survival (PFS).
- Physical function will be assessed using the PROMIS Physical Function Short Form PRO 4a.
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| Follow-up Visits and Length of Follow-up |
Length of follow-up for two years.
Baseline and return visits every 7 to 8 weeks:
- Oral Exam and ECOG performance status
- Review for Calcium Channel Blockers
- Serious Adverse Device Events (NCI-CTCAE v5.0)
- Serious Adverse Events (NCI-CTCAE v5.0)
- PT/INR, CBC, CMP (according to Standard of Care)
- Alpha-fetoprotein (only if Screening/Baseline is greater than 30 ng/mL)
- Radiologic disease assessment (according to Standard of Care)
- ECOG PS (Once every week for 3 weeks(3 Measurements), then every other week for the next 6 weeks (3 Measurements), then every month afterwards)
- Device Use Reconciliation
- PROMIS Pain Intensity, Pain Interference, Physical Function (Once every week for 3 weeks(3 Measurements), then every other week for the next 6 weeks (3 Measurements), then every month afterwards)
- PRO-CTCAE items
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