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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT03192735
Eligibility Criteria:
Inclusion Criteria:
1. Age from 18 to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
5. Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
6. Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
7. Estimate life is equal or greater than 3 months
8. No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection
9. The main organ function is normal,and meet the following criteria:
* blood routine examination( No blood transfusion within 14 days)
1. HB≥100g/L，
2. WBC≥3.5×109/L
3. ANC≥1.5×109/L，
4. PLT≥100×109/L；
* blood biochemical examination
1. BIL \<1.5 Upper Limit Of Normal（ULN），
2. ALT and AST\<2.5ULN，GPT≤1.5×ULT；
3. Cr≤1ULN，creatinine clearance\>60ml/min（Cockcroft-Gault formula）
10. Written informed consent
Exclusion Criteria:
1. Pregnant and lactating women
2. Suffering from severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous chemotherapy or radiotherapy therapy
5. History of other malignant disease within the past 5 years
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of unstable angina or myocardial infarction within the past 6 months
8. History of cerebrovascular accident within the past 6 months
9. History of continuous systematic administration of corticosteroids within 1 month
10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
11. Patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),The history of hematemesis and melena within 2 months,coagulation disorders(INR\>1.5、APTT\>1.5 ULN).
12. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content\>1.0g)
13. There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction
14. Drug allergy to experimental medicine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03192735
Study Brief:
Protocol Section:
NCT03192735