Pancreatic Tumourshisto-pancreasNCT07873606
Histotripsy x Pancreatic Cancer
A study testing Histotripsy in people with Pancreatic Tumours, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) remains one of the deadliest malignancies, with 5-year survival around 12% despite advances in surgery, chemotherapy, and radiotherapy. Existing ablative therapies (RFA, microwave, irreversible electroporation) are limited by thermal injury risk, proximity to vessels/ducts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Tumours
- What is being tested?
- Histotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Mar 2026to 25 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Fit for general anaesthesia
- Unresectable pancreatic cancer with, or without vascular encasement
- With or without distant metastasis
- Without portal vein thrombosis
- Good performance status:
- Tumour visible and targetable by ultrasound with acceptable acoustic windows
- Adequate hematologic, hepatic, and renal function
Who cannot join
- Refusal to take part in clinical trial
- Portal vein thrombosis present
- Not fit for general anaesthesia
- Poor general condition with limited life expectancy
- Uncontrolled coagulopathy
- Extensive bowel interposition preventing safe targeting, per recent porcine safety data linking mis-targeting to bowel injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Albert Chan, MBBS, MS, +85222553025, acchan@hku.hk
Albert Chan, MBBS, MS
About this study
Official title: Histotripsy for Pancreatic Cancer: a Novel Strategy for an Unmet Need
Pancreatic ductal adenocarcinoma (PDAC) remains one of the deadliest malignancies, with 5-year survival around 12% despite advances in surgery, chemotherapy, and radiotherapy. Existing ablative therapies (RFA, microwave, irreversible electroporation) are limited by thermal injury risk, proximity to vessels/ducts. Novel local therapies that can be integrated with systemic regimens are urgently needed. Histotripsy is a non-thermal focused ultrasound modality that uses controlled cavitation to mechanically liquefy tissue without thermal coagulation or ionizing radiation, with precision under real-time ultrasound guidance. Preclinical and early translational work in pancreatic models shows that histotripsy can safely ablate pancreatic tissue while sparing major vessels and ducts in large-animal models, and can alter the tumour microenvironment (TME) with increased release of damage-associated molecular patterns (DAMPs), enhanced dendritic cell and macrophage activation, and increased CD8+ T-cell infiltration in murine pancreatic tumours.
This proposal aims to evaluate the safety, local tumour control, and immunologic effects of histotripsy in pancreatic cancer especially PDAC, positioning it as a platform to enhance responsiveness to contemporary systemic therapies.
The HistoSonics Histotripsy System is now registered in the Medical Device Administration Control System from Department of Health in Hong Kong (HKMD no: 252842).
- Conditions
- Pancreatic Tumours
- Being tested
- Histotripsy
- Keywords
- pancreatic tumours, pancreatic cancer, pancreatic disease, histotripsy, pancreatic neoplasm
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistotripsyRadiation
Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue.
Other Name:
| Study group | Role | What they receive |
|---|---|---|
| Histotripsy | Other | Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures Receives: Radiation: Histotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post procedure events
safety monitoring
Measured: duration of hospital stay, normally 3 days on average
changes in tumour feature
changes in tumour size by serial interval scans
Measured: up to 2 years
Secondary outcomes (1)
Questionnaire based pain assessment
to evaluate patient-reported pain level before and after Histotripsy
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start31 Mar 2026
- Primary completion25 Jan 2028 (estimated)
- Study completion25 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic TumoursStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Chi Yan Chan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873606
- Sponsor's protocol ID
- GHK-2026-001
- Acronym
- histo-pancreas
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histotripsy for Pancreatic Cancer: a Novel Strategy for an Unmet Need
- ClinicalTrials.gov ID
- NCT07873606
- Acronym / sponsor ID
- histo-pancreas / GHK-2026-001
- Conditions
- Pancreatic Tumours
- Keywords
- pancreatic tumours, pancreatic cancer, pancreatic disease, histotripsy, pancreatic neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 25 Jan 2028 (estimated)
- Study completion
- 25 Jan 2028 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic ductal adenocarcinoma (PDAC) remains one of the deadliest malignancies, with 5-year survival around 12% despite advances in surgery, chemotherapy, and radiotherapy. Existing ablative therapies (RFA, microwave, irreversible electroporation) are limited by thermal injury risk, proximity to vessels/ducts. Novel local therapies that can be integrated with systemic regimens are urgently needed. Histotripsy is a non-thermal focused ultrasound modality that uses controlled cavitation to mechanically liquefy tissue without thermal coagulation or ionizing radiation, with precision under real-time ultrasound guidance. Preclinical and early translational work in pancreatic models shows that histotripsy can safely ablate pancreatic tissue while sparing major vessels and ducts in large-animal models, and can alter the tumour microenvironment (TME) with increased release of damage-associated molecular patterns (DAMPs), enhanced dendritic cell and macrophage activation, and increased CD8+ T-cell infiltration in murine pancreatic tumours.
This proposal aims to evaluate the safety, local tumour control, and immunologic effects of histotripsy in pancreatic cancer especially PDAC, positioning it as a platform to enhance responsiveness to contemporary systemic therapies.
The HistoSonics Histotripsy System is now registered in the Medical Device Administration Control System from Department of Health in Hong Kong (HKMD no: 252842).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histotripsy | Other | Radiation: HistotripsyHistotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old
- Fit for general anaesthesia
- Unresectable pancreatic cancer with, or without vascular encasement
- With or without distant metastasis
- Without portal vein thrombosis
Key exclusion criteria (6 listed)
- Refusal to take part in clinical trial
- Portal vein thrombosis present
- Not fit for general anaesthesia
- Poor general condition with limited life expectancy
- Uncontrolled coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistotripsyHistotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. Other Name: | Radiation | Histotripsy |
Primary outcome
post procedure events
Time frame: duration of hospital stay, normally 3 days on average
safety monitoring
changes in tumour feature
Time frame: up to 2 years
changes in tumour size by serial interval scans
1 secondary outcome
Questionnaire based pain assessment
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histotripsy in people with Pancreatic Tumours, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Chan, MBBS, MS (+85222553025, acchan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post procedure events (time frame: duration of hospital stay, normally 3 days on average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.