Table 1.
Inclusion | Exclusion |
Informed consent as documented by signature | Predominant extraperitoneal metastases at the discretion of the study team after discussion at the multidisciplinary tumour board |
Age ≥18 years | Bowel obstruction, active gastroduodenal ulcer or ongoing abdominal infection (bacterial, viral or fungal) |
Who are psychologically able to follow the trial procedures | Chemotherapy or surgery within the last 2 weeks prior to enrolment |
With peritoneal carcinomatosis from pancreatic, oesogastric, epithelial ovarian cancers or primitive peritoneal mesothelioma | General or local (abdominal) contra-indications for laparoscopic surgery |
Not candidate for surgical cytoreduction and IP/HIPEC based on expert multidisciplinary board | Known allergy to cisplatin or other platinum-containing compounds or to compounds of similar chemical or biological composition of nab-paclitaxel |
Who received at least one line of chemotherapy and for whom standard therapies have been exhausted or not feasible. Patients with residual disease following the first line of therapy or following secondary debulking are eligible. | Severe organ dysfunction including: renal impairment (calculated GFR <60 mL/min/1.73 m2); myelosuppression (platelet count <100 x10∧9/L, haemoglobin <90 g/L, neutrophil granulocytes <1.500 /mL); INR ≥2; hepatic impairment (serum total bilirubin ≥1.5 mg/dL, AST/ALT >1.5 x ULN); severe respiratory or neurological impairment (grade 3); severe myocardial insufficiency (NYHA class >2), recent myocardial infarction, severe arrhythmias |
ECOG 0, 1 or 2 | Pregnancy or breastfeeding, women who can become pregnant must ensure effective contraception |
Life expectancy >3 months | Known or suspected non-compliance, inability to follow the procedures of the study, for example, due to language problems, psychological disorders, dementia, etc of the participant |
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECOG, Eastern Cooperative Oncology Group performance status scale; GFR, glomerular filtration rate; HIPEC, hyperthermic intraperitoneal chemotherapy; INR, international normalised ratio; IP, intraperintoaneal; NYHA, New York Heart Association functional classification; ULN, upper limit of normal.