Peritoneal MetastasesPhase 2PIPACNCT06367270
The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies
A Phase 2 study testing Pressured Intraperitoneal Aerosol Chemotherapy in people with Peritoneal Metastases, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Metastases
- What is being tested?
- Pressured Intraperitoneal Aerosol Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2023to 31 Aug 2027
- Phase
- Phase 2
- 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
- ≥18 years of old;
- WHO performance of status 0-1;
- Histologically or cytologically proven PM of a gastric, pancreatic or colorectal carcinoma;
- Treatment naïve patients as first-line treatment;
- Progression on or intolerance to first-line systemic chemotherapy as second-line treatment;
- No symptoms of gastrointestinal obstruction;
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- No contraindications for the planned systemic therapy or laparoscopy;
- No previous PIPAC/IP/HIPEC;
- No other concurrent malignancies or any other malignancy within 6 months prior to enrolment;
- Able to give written informed consent.
Who cannot join
- A history of allergic reaction to platinum containing compounds or doxorubicin;
- Pregnant or breastfeeding;
- Any extra-peritoneal metastases;
- Renal impairment, defined as GFR less than 40 mL/min;
- Impaired liver function defined as bilirubin over 1.5 × UNL;
- Inadequate haematological function
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- Leucocyte < 3.00 × 109/L
- Absolute neutrophil counts < 1.50 × 109/L
- Platelet < 100 × 109/L
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
Queen Mary Hospital
Hong Kong
Ian WONG, Dr., +852 2255 4774, iyhwong@hku.hk
Ian WONG, Dr.
About this study
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Currently available evidence on feasibility, efficacy and tolerability in Asian populations is limited. In this open-label, single-arm, monocentric clinical trial, investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM. Alternative regimen can be considered multidisciplinary tumour board meeting. Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy. The goal was to repeat PIPAC every 6-8 weeks for at least three procedures, and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure. If PM was considered to become resectable during PIPAC, patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary outcome is the clinical benefit rate (CBR), measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors (RECIST) and Peritoneal Cancer Index (PCI) assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes. Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events (CTACE) up to 4 weeks after the treatment, Cytological tumour response of peritoneal lavage or ascites, treatment-related characteristics, hospital stay, progression-free survival, overall survival and readmission rate. The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity.
- Conditions
- Peritoneal Metastases
- Being tested
- Pressured Intraperitoneal Aerosol Chemotherapy
- Keywords
- Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC), Peritoneal metastases, Oxaliplatin, Intraperitoneal chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressured Intraperitoneal Aerosol ChemotherapyDrug
Also called PIPAC
PIPAC cycles will be scheduled every 6-8 weeks and 2 weeks after the last systemic chemotherapy administration. The bidirectional program for the combination of intraperitoneal and systemic chemotherapy is designed as follows: systemic chemotherapy followed by PIPAC two weeks later, followed by a one-week interval, and then systemic chemotherapy once again until three PIPAC cycles have been completed. Up to a one-week delay in returning to systemic chemotherapy after PIPAC and vice versa were considered acceptable. Systemic drug choice was based on previous chemotherapy exposure and the medical oncologists' decision. The study ends after the 3rd cycle of PIPAC.
| Study group | Role | What they receive |
|---|---|---|
| PIPAC | Experimental | Not described Receives: Drug: Pressured Intraperitoneal Aerosol Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate (CBR)
Clinical benefit rate (CBR) according to Response Evaluation Criteria In Solid Tumors (RECIST).
Measured: At the end of Cycle 3 (each cycle is 6 to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. WONG, Yu Hong Ian, The University of Hong Kong
- Investigators
- Ian WONG, Dr., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367270
- Sponsor's protocol ID
- UW 23-361
- Acronym
- PIPAC
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies
- ClinicalTrials.gov ID
- NCT06367270
- Acronym / sponsor ID
- PIPAC / UW 23-361
- Conditions
- Peritoneal Metastases
- Keywords
- Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC), Peritoneal metastases, Oxaliplatin, Intraperitoneal chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Apr 2024 (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.
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Currently available evidence on feasibility, efficacy and tolerability in Asian populations is limited. In this open-label, single-arm, monocentric clinical trial, investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM. Alternative regimen can be considered multidisciplinary tumour board meeting. Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy. The goal was to repeat PIPAC every 6-8 weeks for at least three procedures, and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure. If PM was considered to become resectable during PIPAC, patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary outcome is the clinical benefit rate (CBR), measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors (RECIST) and Peritoneal Cancer Index (PCI) assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes. Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events (CTACE) up to 4 weeks after the treatment, Cytological tumour response of peritoneal lavage or ascites, treatment-related characteristics, hospital stay, progression-free survival, overall survival and readmission rate. The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIPAC | Experimental | Drug: Pressured Intraperitoneal Aerosol Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥18 years of old;
- WHO performance of status 0-1;
- Histologically or cytologically proven PM of a gastric, pancreatic or colorectal carcinoma;
- Treatment naïve patients as first-line treatment;
- Progression on or intolerance to first-line systemic chemotherapy as second-line treatment;
Key exclusion criteria (9 listed)
- A history of allergic reaction to platinum containing compounds or doxorubicin;
- Pregnant or breastfeeding;
- Any extra-peritoneal metastases;
- Renal impairment, defined as GFR less than 40 mL/min;
- Impaired liver function defined as bilirubin over 1.5 × UNL;
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 |
|---|---|---|
| Pressured Intraperitoneal Aerosol ChemotherapyAlso: PIPACPIPAC cycles will be scheduled every 6-8 weeks and 2 weeks after the last systemic chemotherapy administration. The bidirectional program for the combination of intraperitoneal and systemic chemotherapy is designed as follows: systemic chemotherapy followed by PIPAC two weeks later, followed by a one-week interval, and then systemic chemotherapy once again until three PIPAC cycles have been completed. Up to a one-week delay in returning to systemic chemotherapy after PIPAC and vice versa were considered acceptable. Systemic drug choice was based on previous chemotherapy exposure and the medical oncologists' decision. The study ends after the 3rd cycle of PIPAC. | Drug | PIPAC |
Primary outcome
Clinical benefit rate (CBR)
Time frame: At the end of Cycle 3 (each cycle is 6 to 8 weeks)
Clinical benefit rate (CBR) according to Response Evaluation Criteria In Solid Tumors (RECIST).
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 30 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Metastases
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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.
Ian WONG, Dr. principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pressured Intraperitoneal Aerosol Chemotherapy in people with Peritoneal Metastases, 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 10 inclusion and 9 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 30 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ian WONG, Dr. (+852 2255 4774, iyhwong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit rate (CBR) (time frame: At the end of Cycle 3 (each cycle is 6 to 8 weeks)). 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 30 Apr 2026.