Peritoneal MetastasesPhase 1NCT04956068
PIPAC for Peritoneal Metastases
A Phase 1 study testing PIPAC in people with Peritoneal Metastases, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Peritoneal Metastases
- What is being tested?
- PIPAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- 20 May 2021to Nov 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Unesectable PM Group:
- Age ≥ 21 years old
- ECOG < 3
- Fit for systemic chemotherapy treatment
- Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L
- Adequate renal function (e-GFR > 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR > 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin)
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- Adequate liver function (Total bilirubin < 1.5 upper limit of normal; ALT and AST< 3 upper limit of normal)
- No contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin
- No contraindications to general anaesthesia and diagnostic laproscopy procedure
- Normal left ventricular ejection fraction (for patients undergoing PIPAC with doxorubicin/ cisplatin)
- Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcoma primaries
- Peritoneal-dominant metastatic disease
- For the Extensive PM Group:
- All the above mentioned criteria as for the unresectable group, with the addition of the following:
- Not suitable for curative cytoreductive surgery (CRS) \& hyperthermic intraperitoneal chemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI > 18 in LGI, PCI > 6 in UGI ECOG < 3
- In UGI PM patients, progression while on bidirectional chemotherapy
Who cannot join
- Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases
- Any medical or psychiatric condition(s) which would preclude informed consent
- Patient is pregnant or nursing
- GI PM patients with PCI >6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. It was devised to palliate the local symptoms of extensive peritoneal metastases (PM) in patients who are not amenable to curative surgery. This study is to determine safety and feasibility of PIPAC in patients with PM from Gastrointestinal (GI) cancer, Hepato-Pancreato-Biliary (HPB) cancer, and other rare malignancies.
- Conditions
- Peritoneal Metastases
- Being tested
- PIPAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPACCombination product
A novel drug delivery system using the CapnoPen device which allows the aerolisation of chemotherapeutic agents within the peritoneal cavity. PIPAC procedure will be carried out with either oxaliplatin or doxorubicin/ cisplatin.
| Study group | Role | What they receive |
|---|---|---|
| Unresectable PM group | Experimental | Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy. Receives: Combination Product: PIPAC |
| Extensive PM group | Experimental | Patients who have significant volume of peritoneal disease are treated with the intent for potential conversion to curative surgery. Role of PIPAC is as an adjunct to systemic chemotherapy to downstage peritoneal metastases. Receives: Combination Product: PIPAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major toxicities of at least CTCAE Grade 3 and above
To determine and safety and feasibility of PIPAC in patients with PM. Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Measured: Up to 4 weeks after each PIPAC procedure
Number of patients with minor toxicities of CTCAE Grade 1 and 2
Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Measured: Up to 4 weeks after each PIPAC procedure
Length of hospitalisation stay for each PIPAC procedure
Measured: Through study completion, an average of half a year
Secondary outcomes (8)
Intra-operative Peritoneal Carcinomatosis Index (PCI) score
To examine the clinical response of PM after PIPAC. PCI score from 0 to 39 with a higher number representing a greater amount of disease present in the peritoneum.
Measured: During each PIPAC procedure
Ascites volume
To examine the clinical response of PM after PIPAC
Measured: During each PIPAC procedure
Peritoneal Regression Grading Score (PRGS) from PM biopsy
To examine the clinical response of PM after PIPAC
Measured: At each PIPAC procedure
Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Range: 0-108. A high score represents a better health state
Measured: At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure)
Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire
Range: 0-100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measured: At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure)
Progression free survival
Measured: From the start of the first PIPAC procedure, up to 5 years
Overall survival
Measured: From the start of the first PIPAC procedure, up to 5 years
Percentage of patients that convert to curative surgery
(Only applicable for Extensive PM group)
Measured: From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start20 May 2021
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: Awaiting further funding.
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claramae Chia, MBBS, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956068
- Sponsor's protocol ID
- PIPAC
- Status last verified
- May 2026
- First submitted
- 24 May 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT04956068
- Acronym / sponsor ID
- PIPAC
- Conditions
- Peritoneal Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Awaiting further funding.
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Jul 2021 (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 drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. It was devised to palliate the local symptoms of extensive peritoneal metastases (PM) in patients who are not amenable to curative surgery. This study is to determine safety and feasibility of PIPAC in patients with PM from Gastrointestinal (GI) cancer, Hepato-Pancreato-Biliary (HPB) cancer, and other rare malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unresectable PM group | Experimental | Combination Product: PIPACPatients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy. |
| Extensive PM group | Experimental | Combination Product: PIPACPatients who have significant volume of peritoneal disease are treated with the intent for potential conversion to curative surgery. Role of PIPAC is as an adjunct to systemic chemotherapy to downstage peritoneal metastases. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 21 years old
- ECOG < 3
- Fit for systemic chemotherapy treatment
- Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L
- Adequate renal function (e-GFR > 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR > 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin)
Key exclusion criteria (4 listed)
- Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases
- Any medical or psychiatric condition(s) which would preclude informed consent
- Patient is pregnant or nursing
- GI PM patients with PCI >6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
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 |
|---|---|---|
| PIPACA novel drug delivery system using the CapnoPen device which allows the aerolisation of chemotherapeutic agents within the peritoneal cavity. PIPAC procedure will be carried out with either oxaliplatin or doxorubicin/ cisplatin. | Combination product | Extensive PM group, Unresectable PM group |
Primary outcome
Number of patients with major toxicities of at least CTCAE Grade 3 and above
Time frame: Up to 4 weeks after each PIPAC procedure
To determine and safety and feasibility of PIPAC in patients with PM. Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Number of patients with minor toxicities of CTCAE Grade 1 and 2
Time frame: Up to 4 weeks after each PIPAC procedure
Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.
Length of hospitalisation stay for each PIPAC procedure
Time frame: Through study completion, an average of half a year
8 secondary outcomes
Intra-operative Peritoneal Carcinomatosis Index (PCI) score
Time frame: During each PIPAC procedure
Ascites volume
Time frame: During each PIPAC procedure
Peritoneal Regression Grading Score (PRGS) from PM biopsy
Time frame: At each PIPAC procedure
Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Time frame: At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure)
Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire
Time frame: At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure)
Progression free survival
Time frame: From the start of the first PIPAC procedure, up to 5 years
Overall survival
Time frame: From the start of the first PIPAC procedure, up to 5 years
Percentage of patients that convert to curative surgery
Time frame: From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Claramae Chia, MBBS principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PIPAC in people with Peritoneal Metastases, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 16 inclusion and 4 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: paused, as of the sponsor's last update on 13 May 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 Singapore. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with major toxicities of at least CTCAE Grade 3 and above (time frame: Up to 4 weeks after each PIPAC procedure). The study lists 3 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 13 May 2026.