Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT05277766
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05277766
Study Brief:
Protocol Section:
NCT05277766