PIPAC in Gastric Peritoneal Metastasis

Plain-language summary

This study looks at the drugs Cisplatin and Doxorubicin delivered by pressurized intraperitoneal aerosol chemotherapy (PIPAC) in people whose gastric (stomach) cancer has spread to the lining of the abdomen (peritoneal metastasis). Patients aged 18 to 80 with peritoneal metastasis from gastric adenocarcinoma may take part. It is being carried out in Phase 2 and is enrolling by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Enrolling by invitation

Sponsor

Chinese University of Hong Kong

Intervention

Cisplatin and Doxorubicin

Start date

10/11/2021

Estimated completion

2/28/2031

Countries

Hong Kong

Related genes

Locations

• Hong Kong, Hong Kong

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Patients age \>= 18, \<= 80 years old
2. Performance status (WHO) \<=2
3. Histologically evidenced synchronous PM of gastric adenocarcinoma cancer
4. Peritoneal Cancer Index (PCI) score \> 8, or \<=8 and patient not fit for cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (CRS + HIPEC)
5. Patients with isolated ovarian metastasis could be included
6. White blood cells \>3.5000/mm3; neutrophils \> 1.500/mm3; platelets \>100,000/mm3
7. Creatinine \<1.5mg/dL and creatinine clearance \>60ml/min and serum total bilirubin \<2mg/dL
8. Ability to give written consent prior to commencement of treatment

Exclusion Criteria:

1. Extraperitoneal metastases including liver metastases and malignant pleural effusion. The presence of suspicious retroperitoneal lymph nodes is not an exclusion criterium.
2. Patients with adenocarcinoma of Siewart I
3. Bowel obstruction, not tolerating oral diet
4. HER2+++ tumor with indicated for Trastuzumab therapy
5. Any laparotomy during 3 months before inclusion. (Laparoscopy is not an exclusion criterium)
6. Contraindicated to any drug contained in the chemotherapy regimen
7. Concomitant intraperitoneal chemotherapy, immunotherapy or target therapy
8. Active infectious (bacterial, viral) disease. Elevated CRP with no identified focus is not an exclusion criterium
9. Pregnancy or breastfeeding