PIPAC for Peritoneal Metastases

National Cancer Centre, Singapore

Status and phase: Enrolling; Phase 1

Conditions: Peritoneal Metastases

Treatments: Combination Product: PIPAC

Study type: Interventional

Funder types: Other

Identifiers

NCT04956068

PIPAC

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Unresectable PM group

Experimental group

Description:

Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy.

Treatment:

Combination Product: PIPAC

Extensive PM group

Experimental group

Description:

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.

Treatment:

Combination Product: PIPAC