PIPAC for Peritoneal Metastases

Phase 1

Recruiting

• Conditions: Peritoneal Metastases
• Interventions: Combination Product: PIPAC

• Registration Number: NCT04956068
• Lead Sponsor: National Cancer Centre, Singapore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extensive PM group	PIPAC	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.
Unresectable PM group	PIPAC	Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy.

Primary Outcome Measures

Name	Time	Method
Number of patients with major toxicities of at least CTCAE Grade 3 and above	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	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	Through study completion, an average of half a year

Secondary Outcome Measures

Name	Time	Method
Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire	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)	Range: 0-108. A high score represents a better health state
Ascites volume	During each PIPAC procedure	To examine the clinical response of PM after PIPAC
Percentage of patients that convert to curative surgery	From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks	(Only applicable for Extensive PM group)
Intra-operative Peritoneal Carcinomatosis Index (PCI) score	During each PIPAC procedure	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.
Peritoneal Regression Grading Score (PRGS) from PM biopsy	At each PIPAC procedure	To examine the clinical response of PM after PIPAC
Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire	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)	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.
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

Trial Locations

Locations (1)

National Cancer Center Singapore; 🇸🇬 Singapore, Singapore