Chemotherapy sprayed directly into the abdomen: a new attack on stubborn cancers
NCT ID NCT05277766
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This phase 1 trial tests a new method of delivering chemotherapy for people with cancers that have spread to the lining of the abdomen (peritoneal carcinomatosis) from gastrointestinal cancers like colorectal, stomach, or pancreatic cancer. The drug, nanoliposomal irinotecan (Onivyde), is given as a pressurized aerosol spray directly into the abdomen during a minimally invasive procedure called PIPAC. The main goal is to find the highest safe dose and to watch for side effects, with a secondary aim of determining a dose for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nanoliposomal irinotecan (Onivyde)
- What this could lead to
- If successful, this could establish a safe dose for a new way to deliver chemotherapy directly to abdominal tumors, potentially improving control of peritoneal carcinomatosis.
- What could go wrong
- This is an early phase 1 trial with a small number of participants, so the main goal is safety, not proof of effectiveness. The treatment may cause serious side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2022
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis * Estimated life expectancy \> 6 months; \> 3 months if primary cancer is pancreatic * Age ≥ 18 years * Adequate performance status (Karnofsky index \> 60% and WHO performance status \< 2) * Written informed consent obtained prior any act of the research Exclusion Criteria: * Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI) * Pregnancy or breastfeeding during the clinical study * Patients of childbearing age unable or unwilling to provide effective contraception during the study and until the end of relevant exposure (extended by 30 days (female participants) or 120 days (male participants) since the IMP is genotoxic). * Known allergy or intolerance to irinotecan * Significant amount of ascites detectable (exceeding 3l in volume) * Intestinal or urinary tract obstruction * Extensive hepatic and/or extra-abdominal metastatic disease * Impaired renal function (serum creatinine \> 1.5 mg/dl or calculated GFR (CKD-EPI) \< 60 mL/min/1.73 m² * Impaired liver function (serum total bilirubin \> 1.5 mg/dl, except for known Gilbert's disease) * Platelet count \< 100.000/µl * Hemoglobin \< 9g/dl * Neutrophil granulocytes \< 1.500/ml * Patients known to use: * CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort) * inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Appendix cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UZ Ghent
Ghent, East-Flanders, 9000, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma
- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
- A phase II study of total neoadjuvant mFOLFOX6 plus suvemcitug and enlonstobart with selective omission of pelvic radiotherapy for High-Risk Mid-Rectal locally advanced rectal cancer with MSS status
- Leveraging digital health solutions to collect Patient-Reported outcomes in rectal cancer
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?
- Can a new drug combo outsmart RAS-Mutated pancreatic cancer?