PIPAC is a procedure that involves the administration of intraperitoneal chemotherapy using an innovative concept that enhances the efficacy by taking advantage of the physical properties of gas and pressure. The chemotherapy drugs will be delivered in aerosolised form. This results in a superior distribution and depth of penetration of the drug.
This research study serves to determine the safety profile and tolerability of PIPAC with oxaliplatin. It may offer a novel and effective option of treatment for patients with peritoneal carcinomatosis, who, at present have limited options involving the use of systemic chemotherapy and who suffer from poor life expectancy and poor quality of life.
To date, most trials have used PIPAC cisplatin with doxorubicin, or oxaliplatin alone, and more studies are on-going globally.
Intravenous (IV) nivolumab has been approved for the treatment of progressive gastric cancer after conventional chemotherapy. PIPAC in combination with nivolumab may have the potential to improve immune activation and response to immune checkpoint inhibition for patients with peritoneal disease.
Hence we propose an amendment to our trial protocol for the addition of a second cohort (Cohort 2) to investigate the safety and tolerability of the combination of PIPAC oxaliplatin and IV nivolumab.
Who can participate
Age range
21 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 for Cohort 1:
* Gastric cancer patients with peritoneal metastasis on peritoneal cytology/histology.
* Patients who refuse, are unable to tolerate, or have completed at least 1st line systemic chemotherapy.
* Patients who have completed chemotherapy/targeted therapy \> 21 days or at least 5 half-lives (or whichever is longer) prior to PIPAC.
* Age \>21 years.
* Eastern Cooperative Oncology Group performance status 0-1.
* Adequate bone marrow function (neutrophil count \>1500/mm3, hemoglobin \>8.0 g/dl and platelet count \>100 000/mm3).
* Adequate liver function (bilirubin, AST/ALT within upper limit of normal)
* Adequate renal function (serum creatinine within the upper limit of normal)
* Expected survival \>3 months
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion Criteria for Cohort 1:
* Predominant extra-peritoneal metastases at the discretion of the study team after discussion at the multidisciplinary tumour board
* Good response to systemic chemotherapy based on RECIST guidelines VI.I with complete or partial response to systemic chemotherapy.
* Known allergy to oxaliplatin
* Previous malignancy unrelated to current peritoneal carcinomatosis diagnosed in the last 5 years
* Patients with treated skin cancer besides melanoma may be included.
* Patients with reproductive potential who refuse to use an adequate means of contraception (including…
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
Safety Profile of PIPAC with oxaliplatin by monitoring adverse event profile of patient undergo PIPAC
Timeframe: 1 to 2 years
2
Tolerability of PIPAC with oxaliplatin by monitoring dose limiting toxicities
Timeframe: 1-2 years
3
Safety Profile of PIPAC with oxaliplatin in combination with IV nivolumab by monitoring adverse event profile of patient undergo PIPAC
Timeframe: 1-2 years
4
Tolerability of PIPAC with oxaliplatin in combination with IV nivolumab by monitoring dose limiting toxicities