Study on the effects of surgery and HIPEC for peritoneal carcinomatosis
Official title: Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses
Run by University of Regensburg · NCT04108936 · Data updated 2026-11-12
This study is testing how surgery and a special type of heated chemotherapy can affect the immune system and gut bacteria in people with peritoneal carcinomatosis to see how it impacts their health and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | University of Regensburg Academic / other |
| Locations | 2 sites (Regensburg, Bavaria and 1 other locations) |
| Status | Recruiting |
| Started | October 2016 |
| Main results expected | July 2026 |
| Study ends | July 2028 |
| Registry record updated | August 23, 2022 |
| Trial ID | NCT04108936 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with suspicious peritoneal carcinomatosis.
✕Probably not a fit
Patients under 18 years old will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study conducts a longitudinal analysis of patients with peritoneal carcinomatosis undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). It aims to evaluate cellular immune responses and microbiome changes in relation to disease outcomes. Additionally, the study will assess renal function concerning different HIPEC regimens and identify clinical surrogate parameters that may predict patient outcomes.
Why it matters
Potential benefit: If successful, this study could enhance understanding of immune responses and treatment efficacy in patients with peritoneal carcinomatosis, potentially leading to improved patient outcomes.
How similar studies have gone: While there have been studies on HIPEC, this specific longitudinal approach focusing on immune responses and microbiomes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * suspicious peritoneal carcinomatosis Exclusion Criteria: * \<18 years
Where it's running
-
University Hospital Regensburg
Regensburg, Germany Recruiting -
Krankenhaus der Barmherzigen Brüder Regensburg
Regensburg, Bavaria, Germany Not yet recruiting
Study contacts
- Principal investigator: Jens M Werner, MD — Dept. of Surgery, University Hospital Regensburg
- Study coordinator: Jens M Werner, MD
- Email: Jens.Werner@ukr.de
- Phone: +49941944
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Repeated PIPAC plus standard platinum–taxane chemotherapy for advanced ovarian cancer with peritoneal spread
This test sees if adding repeated cisplatin-based PIPAC to standard platinum–taxane chemotherapy helps women aged 18–75 with newly diagnosed FIGO IIIB–IIIC epithelial ovarian cancer and visible peritoneal carcinomatosis.
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Enhanced Recovery After Surgery for adults with peritoneal carcinomatosis undergoing cytoreductive surgery with or without HIPEC
This project will try an Enhanced Recovery After Surgery (ERAS) program to see if it shortens hospital stays after cytoreductive surgery with or without HIPEC for adults with peritoneal carcinomatosis.
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PIPAC with Mitomycin C for unresectable peritoneal cancer
This phase 1 study tests a breathy, pressurized chemotherapy method (PIPAC-MMC) to see if it is safe and tolerable for adults with unresectable peritoneal carcinomatosis from colorectal, appendiceal, or small bowel cancers.
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Heated versus aerosolized chemotherapy delivered into the abdomen for cancer that has spread to the peritoneum
This study will test whether heated (HIPEC) or aerosolized (PIPAC) mitomycin-based chemotherapy given into the abdomen works better and is safer for adults whose cancer has spread to the peritoneum.
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Adding paclitaxel into the abdominal cavity for gastric cancer that has spread to the peritoneum
This trial will try adding paclitaxel delivered directly into the abdomen to standard IV chemotherapy for people with gastric or gastroesophageal junction cancer that has spread to the lining of the abdominal cavity to see if it slows disease growth and helps them live longer.
-
Blood clearance of nucleosomes and CTCF after surgery for colorectal cancer with peritoneal spread
This test will see if blood levels of nucleosomes and CTCF can indicate whether adults with colorectal cancer that has spread to the peritoneum have had all visible tumor removed by cytoreductive surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.