PIPAC for Peritoneal Metastases

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.

Study Overview

• Status: Suspended
• Conditions: Peritoneal Metastases
• Intervention / Treatment: Combination product: PIPAC

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169690
    • National Cancer Center Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unresectable PM group; Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy.	Combination product: PIPAC; 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.
Experimental: Extensive PM group; 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.	Combination product: PIPAC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 4 weeks after each PIPAC procedure
Length of hospitalisation stay for each PIPAC procedure		Through study completion, an average of half a year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During each PIPAC procedure
Ascites volume	To examine the clinical response of PM after PIPAC	During each PIPAC procedure
Peritoneal Regression Grading Score (PRGS) from PM biopsy	To examine the clinical response of PM after PIPAC	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	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.	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		From the start of the first PIPAC procedure, up to 5 years
Overall survival		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)	From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks

Collaborators and Investigators

• Sponsor: National Cancer Centre, Singapore
• Investigators: Principal Investigator: Claramae Chia, MBBS, National Cancer Centre, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: PIPAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No