PIPAC for Peritoneal Metastases

Last updated: May 31, 2024
Sponsor: National Cancer Centre, Singapore
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasm Metastasis

Treatment

PIPAC

Clinical Study ID

NCT04956068
PIPAC
  • Ages 21-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withoxaliplatin; e-GFR > 60mls/min for patients undergoing PIPAC withDoxorubicine/Cisplatin)

  • Adequate liver function (Total bilirubin < 1.5 upper limit of normal; ALT and AST< 3upper 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 withdoxorubicin/ cisplatin)

  • Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcomaprimaries

  • 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 intraperitonealchemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI > 18 in LGI, PCI > 6in UGI ECOG < 3

  • In UGI PM patients, progression while on bidirectional chemotherapy

Exclusion

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 undergostandard treatment - bidirectional intravenous and intraperitoneal chemotherapy)

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: PIPAC
Phase: 1
Study Start date:
May 20, 2021
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • National Cancer Center Singapore

    Singapore, 169690
    Singapore

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.