PIPAC for Peritoneal Metastases

Launched by NATIONAL CANCER CENTRE, SINGAPORE · Jun 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver chemotherapy directly into the abdominal cavity for patients with peritoneal metastases, which means cancer that has spread to the lining of the abdomen. The method being tested is called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC). This approach aims to make the chemotherapy more effective and easier to tolerate for patients who cannot undergo surgery to remove their cancer. The trial is specifically focused on patients with advanced gastrointestinal cancers, liver and pancreas cancers, and some other rare cancers.

To participate in this trial, candidates must be at least 21 years old, physically fit enough to handle chemotherapy, and have specific health criteria related to their blood, liver, and kidney functions. They should also have a confirmed diagnosis of peritoneal metastases and not be suitable for traditional surgical treatments. Participants will receive PIPAC treatment in a minimally invasive procedure, and the research team will closely monitor their safety and response to the treatment. It's important to know that the trial is currently looking for volunteers, and interested individuals should discuss with their healthcare providers to see if they qualify.

Gender

ALL

Eligibility criteria

• 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)