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 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT03410732
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent given before any trial-specific procedure is initiated
2. Male or female, at least 18 years of age at the time of informed consent
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
4. Life expectancy \>3 months assessed during Screening
5. Documented (histologically- or cytologically-proven) gastric cancer that is can be radially removed
Exclusion Criteria:
1. Non-healing wounds on any part of the body
2. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to surgery, unless adequately treated and stable
3. Active uncontrolled bleeding or a known bleeding diathesis
4. Significant cardiovascular disease or condition, including:
1. Congestive heart failure currently requiring therapy
2. Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) functional criteria (25)
3. Need for antiarrhythmic medical therapy for a ventricular arrhythmia
4. Severe conduction disturbance (e.g., 3rd degree heart block)
5. Unstable angina pectoris (last episode at least 6 months prior to surgery)
6. Uncontrolled hypertension (per the Investigator's discretion)
7. Myocardial infarction within 6 months prior to C1/D1
5. Abnormal hematologic, renal or hepatic function as defined by the following criteria:
1. Absolute neutrophil count (ANC) \<1.5 ×109/L (1500/mm3)
2. Hemoglobin ≤9 g/dL
3. Platelet count \<75 ×109/L (75,000/mm3)
4. Serum creatinine \>1.5 × upper limit of normal (ULN) for the institution
5. Aspartate aminotransferase (AST) \>3.5 × ULN for the institution or AST \>5 × ULN for the institution in case of known liver metastases
6. Alanine aminotransferase (ALT) \>3.5 × ULN for the institution or ALT \>5 × ULN for the institution in case of known liver metastases
7. Total bilirubin \>1.5 × ULN for the institution
8. Prothrombin time as assessed by International Normalized Ratio (INR) \>1.5 × ULN for the institution\*
9. Partial thromboplastin time (PTT) \>1.5 × ULN for the institution\*
6. Any of the following within 2 weeks prior to surgery:
1. Any serious or uncontrolled infection
2. Any infection requiring parenteral antibiotics
3. Unexplained fever \>38.0 °C
7. Any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the trial treatment
8. Any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with trial procedures or is unwilling or unable to comply with trial requirements at the discretion of the Investigator
9. Breast feeding, or plans by the patient (or the patient's partner) to become pregnant during treatment or within 4 months after the end of treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03410732
Study Brief:
Protocol Section:
NCT03410732