PIPAC for Peritoneal Metastases

NCT04956068 | Recruiting Phase 1

• 1 other identifier: PIPAC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Metastases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Intra-operative Peritoneal Carcinomatosis Index (PCI) score

  During each PIPAC procedure

• Ascites volume

  During each PIPAC procedure

• Peritoneal Regression Grading Score (PRGS) from PM biopsy

  At each PIPAC procedure

• 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)

• 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)

Study Arms (2)

Unresectable PM group

EXPERIMENTAL

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

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.

Combination Product: PIPAC

Interventions

PIPAC COMBINATION_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.

Extensive PM group; Unresectable PM group

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Center Singapore

Singapore, 169690, Singapore

RECRUITING

Study Officials

• Claramae Chia, MBBS

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claramae Chia, MBBS

CONTACT

+65 6436 8000; claramae.chia.s.l@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: July 9, 2021
• Study Start: May 20, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)