NIVOLUMAB for Gastric cancer|Metastatic gastric cancer

Inclusion criteria

• {"criterion_text":"- Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour"}
• {"criterion_text":"- Life expectancy of at least three months."}
• {"criterion_text":"- Male participants are eligible to participate if they agree to the following requirements during the intervention period and for at least 6 months after the last dose of study intervention, which corresponds to the time needed to eliminate reproductive safety risk of the study intervention(s) plus an additional 90 days (a spermatogenesis cycle): o\tRefrain from donating sperm. PLUS either: • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR • Must agree to use contraception/barrier as detailed below. • Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. • Use of an additional highly effective contraceptive method with a failure rate of <1% per year for a female partner of childbearing potential."}
• {"criterion_text":"- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: • Is not a WOCBP. OR • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the intervention period and for at least 9 months after the last dose of study intervention, which corresponds to the time needed to eliminate any reproductive safety risk of the study intervention(s). As for participants using a highly effective method that is user dependent, this contraception method must be used together with a second effective method of contraception. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention."}
• {"criterion_text":"- Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid"}
• {"criterion_text":"- Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment."}
• {"criterion_text":"- Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy."}
• {"criterion_text":"- Adequate bone marrow function (neutrophil count >1500/mm3, hemoglobin >8.0 g/dl and platelet count >100 000/mm3)."}
• {"criterion_text":"- Adequate liver function (bilirubin within 1.5x of the upper limit of normal, AST/ALT within 3x of upper limit of normal)."}
• {"criterion_text":"- Adequate renal function (serum creatinine within1.5x of the upper limit of normal or Glomerular Filtration Rate via Cockcroft-Gault Formula>50mL."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0-1."}
• {"criterion_text":"- Age of at least 18 years."}

Exclusion criteria

• {"criterion_text":"- Comorbidity that does not allow treatment with ST or IP paclitaxel."}
• {"criterion_text":"- Ongoing or recent participation (within 30 days) in a clinical trial with an investigational medicinal product."}
• {"criterion_text":"- Confirmed or suspected severe abdominal adhesions, for example after previous abdominal surgery, which do not allow effective IP paclitaxel treatment."}
• {"criterion_text":"- Distant metastases (including M1 lymph node mestastases according to AJCC 8th edition TNM classification) other than peritoneal, with the specific exception of ovarian, which are permitted."}
• {"criterion_text":"- Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term, i.e within the next three weeks (radiological ascites without significant symptoms is acceptable)."}
• {"criterion_text":"- Gastric cancer peritoneal reccurence which is diagnosed within 6 months after curative intent surgery (patients with recurrence diagnosed 6 months or more after curative intent surgery may be included)."}
• {"criterion_text":"- Severe coagulation disorder which precludes surgical interventions such as staging laparoscopies and SIPC placement"}
• {"criterion_text":"- Previously received more than 2 cycles of palliative-intent systemic chemotherapy (with the specific exception of cytology positive patients without manifest peritoneal metastases) for the current cancer disease."}
• {"criterion_text":"- Another malignancy that can affect survival within the next three years."}
• {"criterion_text":"- Known or suspected allergies against any product included in the trial interventions."}
• {"criterion_text":"- Known DPYD deficiency (including complete and partial deficiency)."}
• {"criterion_text":"- Known MSI-H/dMMR phenotype."}
• {"criterion_text":"- Pregnancy or recent delivery within 28 days postpartum or ongoing breastfeeding."}
• {"criterion_text":"- Active sex-life without use of secure contraceptive method."}
• {"criterion_text":"- If the investigator considers the patient inappropriate for participation in the study for whatever reason."}

Primary endpoints

• {"endpoint_text":"- Overall survival (OS), defined as time from randomisation to death from any cause.","definition_or_measurement_approach":"Defined as time from randomisation to death from any cause."}

Secondary endpoints

• {"endpoint_text":"- Toxicity/adverse Events (AE) according to CTCAE v5.0 in patients treated with IP paclitaxel.","definition_or_measurement_approach":"Assessment of toxicity/AE graded according to CTCAE v5.0."}
• {"endpoint_text":"- HRQoL assessed using EORTC QLQ-C30 and EORTC OG-25 during treatment and follow-up.","definition_or_measurement_approach":"Health-related quality of life measured with EORTC QLQ-C30 and EORTC OG-25 instruments during treatment and follow-up."}
• {"endpoint_text":"- Progression-free survival (PFS), defined as time from randomisation to first documentation of progression according to RECIST1.1, progression of peritoneal carcinomatosis index (PCI), radiological progression of ascites, need for drainage of ascites or death, whichever occurs first.","definition_or_measurement_approach":"Defined as time from randomisation to first documentation of progression per RECIST1.1, progression of PCI, radiological progression of ascites, need for drainage of ascites or death, whichever occurs first."}
• {"endpoint_text":"- Radiological response of treatment on ascites present at baseline.","definition_or_measurement_approach":"Radiological assessment of response of ascites present at baseline (approach not further specified in JSON)."}
• {"endpoint_text":"- Quantifying the amount of ascites drained from the randomisation date to date of censoring, death or end of study.","definition_or_measurement_approach":"Amount (volume) of ascites drained from randomisation until censoring, death or end of study."}
• {"endpoint_text":"- Proportion of patients in each study arm, 1. Fulfilling the criteria for, 2. Undergoing, curative intent conversion surgery.","definition_or_measurement_approach":"Proportion of patients per arm fulfilling criteria for and undergoing curative intent conversion surgery."}

Italy

Earliest CTIS Part Ii Submission Date

16-07-2025

Latest Decision Or Authorization Date

04-08-2025

Processing Time Days

19

Number Of Sites

1

Number Of Participants

18

Netherlands

Earliest CTIS Part Ii Submission Date

03-07-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

165

Number Of Sites

1

Number Of Participants

30

Norway

Earliest CTIS Part Ii Submission Date

15-07-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

132

Number Of Sites

2

Number Of Participants

18

Sweden

Earliest CTIS Part Ii Submission Date

30-06-2025

Latest Decision Or Authorization Date

22-01-2026

Processing Time Days

206

Number Of Sites

5

Number Of Participants

30

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}