CLINICAL TRIAL / NCT04572633
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy
- Interventional
- Active
- NCT04572633
Contact Information
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER US)
This trial is a single arm, non-randomized prospective trial. The objective of this trial is to evaluate the efficacy and safety of the HistoSonics System for the treatment of primary or metastatic tumors located in the liver. The co-primary safety and efficacy endpoints must be met for the trial to be successful.
This trial is a single arm, non-randomized, multicenter, prospective trial. Following
histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours
post-index procedure to determine technical success. Subjects will then be followed for
30 days. Additionally, subjects will be evaluated at 6 months and followed annually for
up to five (5) years post-index procedure.
The #HOPE4LIVER US trial required pooling data from #HOPE4LIVER US and #HOPE4LIVER EU/UK
(NCT04573881). Subjects were treated with the same intervention (HistoSonics System)
using identical protocols tailored to the regulatory requirements for each geography.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. Subject is ≥18 years of age
2. Subject has signed the Ethics Committee (EC) or Institutional Review Board (IRB)
approved trial Informed Consent Form (ICF) prior to any trial related
tests/procedures and is willing to comply with trial procedures and required
follow-up assessments
3. Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets)
from other primary cancers
4. Subject is able to undergo general anesthesia
5. Subject has a Child-Pugh Score of A or B
6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade
0-2 at baseline screening
7. Subject meets the following functional criteria, ≤7 days prior to the
index-procedure:
- Liver function: Alanine transaminase (ALT) and Aspartate transaminase (AST)
<2.5x upper limit of normal (ULN) and/or bilirubin <2.5 ULN, and
- Renal function: serum creatinine <2x ULN, and
- Hematologic function: neutrophil count >1.0 x 10^9/L and platelet >50 x 10^9/L
8. Subject has an International Normalized Ratio (INR) score of <2.0 , ≤7 days prior to
the index procedure
9. Subject has not responded to and/or has relapsed and/or is intolerant of other
available therapies including locoregional therapies, chemotherapy, immunotherapy
and targeted therapies
10. The tumor(s) selected for histotripsy treatment must be ≤3 cm in longest diameter
11. Subject has an adequate acoustic window to visualize targeted tumor(s) using
ultrasound imaging
12. Subject has a maximum of three (3) tumors to be treated with histotripsy during the
index procedure, regardless of how many tumors the subject has.
Exclusion Criteria:
1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the
trial period
2. Subject is enrolled in another investigational trial and/or is taking
investigational medication and/or has been treated with an investigational device
≤30-days prior to planned index procedure date
3. In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s)
that would cause undue risk and preclude safe use of the HistoSonics System
4. Subject has a serum creatinine >2.0 mg/dL or estimated glomerular filtration rate
(EGFR) <30, unless on dialysis
5. Subject has major surgical procedure or significant traumatic injury ≤2 weeks prior
to the planned index procedure or not fully recovered (CTCAE grade 1 or better) from
side effects/complications of such procedure or trauma
6. Subject has not recovered to common terminology criteria for adverse events (CTCAE)
grade 1 or better from any adverse effects (except alopecia, fatigue, nausea,
vomiting and peripheral neuropathy) related to previous anti-cancer therapy
7. Subject has a history of, or suspected to have, bleeding disorders that are
uncorrectable
8. Subject has coagulopathy that is uncorrectable
9. Subject has a planned cancer treatment (e.g. resection, chemotherapy, etc.) after
the planned index-procedure date and prior to completion of the 30-day follow-up
visit
10. Subject has previous treatment with bevacizumab that has not been discontinued >40
days prior to the planned index-procedure date
11. Subject has planned bevacizumab treatment prior to completion of the 30-day
follow-up visit
12. Subject has previous treatments with chemotherapy and/or radiotherapy that has not
been discontinued ≥2 weeks prior to the planned index-procedure date and has not
recovered (CTCAE grade 1 or better) from related toxicity (except alopecia and
peripheral neuropathy)
13. Subject has previous treatment with immunotherapies that has not been discontinued
≥4 weeks prior to the index-procedure and has not recovered from related toxicity
(CTCAE grade 1 or better)
14. Subject has a life expectancy less than six (<6) months
15. In the opinion of the Investigator, histotripsy is not a treatment option for the
subject
16. Subject has a concurrent condition that, in the investigator's opinion, could
jeopardize the safety of the subject or compliance with the protocol
17. Subjects' tumor(s) is not treatable by the System's working ranges (refer to User
Manual)
18. Subject has a known sensitivity to contrast media and cannot be adequately
pre-medicated
19. Subjects' target tumor(s) has/have had prior locoregional therapy (e.g. ablation,
embolization, radiation)
20. Subject is eligible for surgical resection
21. Targeted tumor(s) treatment volume overlaps a non-targeted tumor visible via imaging
22. The targeted tumor(s) is not clearly visible with diagnostic ultrasound and computed
tomography (CT) or magnetic resonance (MR) imaging
23. The targeted tumor(s) is located in liver segment 1
24. The Planned Treatment Volume intended to cover the targeted tumor includes or
encompasses any portion of the main portal vein, common hepatic duct, common bile
duct, gallbladder or stomach/bowel.