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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT05318794
Eligibility Criteria:
Inclusion Criteria:
* Gastric adenocarcinoma (Tx, Nx) 1,2,3
* Peritoneal cytology +ve or PCI ≤ 3
* No solid organ metastasis 2
* HER2 -ve
* Male/female
* Treatment naïve
* BMI ≥ 18.5 kg/m2 or ≤ 40 kg/m2
* WHO performance status ≤ 1
* Dysphagia score ≤ 2
* Informed written consent
Exclusion Criteria:
* PCI ≥ 4
* Solid organ metastasis
* Positive lymph node disease beyond field of D2 lymphadenectomy
* Peritoneal adhesions precluding complete laparoscopy
* Ascites (greater than trace amount)
* Malignant pleural effusion
* Mechanical bowel obstruction (with the exception of gastric outlet obstruction)
* HER2 +ve
* Patients eligible for immunotherapy
* Uncontrolled co-morbidity
* single/multiple organ failure
* BMI \< 18.5 kg/m2 or \> 40 kg/m2
* WHO performance status \> 1
* Dysphagia score \> 2
* Contraindication to chemotherapy
* Pregnancy or breastfeeding
* Haemoglobin \<90 g/dL uncorrected with blood transfusion
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05318794
Study Brief:
Protocol Section:
NCT05318794