SuspendedPhase 1

PIPAC for Peritoneal Metastases

Stopped: Awaiting further funding.

Singapore25 participantsStarted 2021-05-20

Plain-language 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. 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.

Who can participate

Age range

21 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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) * 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 Exclusion Criteria: * Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases * Any m…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with major toxicities of at least CTCAE Grade 3 and above

Timeframe: Up to 4 weeks after each PIPAC procedure

Number of patients with minor toxicities of CTCAE Grade 1 and 2

Timeframe: Up to 4 weeks after each PIPAC procedure

Length of hospitalisation stay for each PIPAC procedure

Timeframe: Through study completion, an average of half a year

Trial details

NCT IDNCT04956068

SponsorNational Cancer Centre, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Peritoneal Metastases trials

Plain-language summary

Who can participate

Age range

21 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of patients with major toxicities of at least CTCAE Grade 3 and above

Timeframe: Up to 4 weeks after each PIPAC procedure

Number of patients with minor toxicities of CTCAE Grade 1 and 2

Timeframe: Up to 4 weeks after each PIPAC procedure

Length of hospitalisation stay for each PIPAC procedure

Timeframe: Through study completion, an average of half a year