PIPAC in Gastric Peritoneal Metastasis (NCT07517419) | Clinical Trial Compass
By InvitationPhase 2
PIPAC in Gastric Peritoneal Metastasis
Hong Kong30 participantsStarted 2021-10-11
Plain-language summary
This is a pilot study aiming at evaluating the effects of PIPAC with Doxorubicin + Cisplastin on patients with PM of gastric cancer. All patients who are diagnosed with gastric cancer with peritoneal metastases in the Prince of Wales Hospital (PWH), HK will be screened for eligibility.
There are two aims for this study:
1. To evaluate safety and efficacy of the procedure together with postoperative outcomes and long term overall and progression free survival.
2. Aim at obtaining tissue samples for molecular analysis and for potential tissue organoids and biobank.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients age \>= 18, \<= 80 years old
. Performance status (WHO) \<=2
. Histologically evidenced synchronous PM of gastric adenocarcinoma cancer
. Peritoneal Cancer Index (PCI) score \> 8, or \<=8 and patient not fit for cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (CRS + HIPEC)
. Patients with isolated ovarian metastasis could be included
. White blood cells \>3.5000/mm3; neutrophils \> 1.500/mm3; platelets \>100,000/mm3
. Creatinine \<1.5mg/dL and creatinine clearance \>60ml/min and serum total bilirubin \<2mg/dL
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality
Timeframe: From recruitment up to five years / death
. Ability to give written consent prior to commencement of treatment
Exclusion criteria
. Extraperitoneal metastases including liver metastases and malignant pleural effusion. The presence of suspicious retroperitoneal lymph nodes is not an exclusion criterium.
. Patients with adenocarcinoma of Siewart I
. Bowel obstruction, not tolerating oral diet
. HER2+++ tumor with indicated for Trastuzumab therapy
. Any laparotomy during 3 months before inclusion. (Laparoscopy is not an exclusion criterium)
. Contraindicated to any drug contained in the chemotherapy regimen
. Concomitant intraperitoneal chemotherapy, immunotherapy or target therapy
. Active infectious (bacterial, viral) disease. Elevated CRP with no identified focus is not an exclusion criterium