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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT04886193
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent of the patient;
2. 18 years old \<age \<80 years old;
3. The primary gastric lesion was diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathology (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por);
4. The clinical stage of laparoscopic exploration is peritoneal metastasis, peritoneal nodule pathologically confirmed metastasis and/or exfoliated cytology test positive for advanced gastric cancer patients;
5. Preoperative ECOG \[Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)\] Physical State Score 0/1;
6. Preoperative anesthesia risk score sheet (ASA score sheet) I-III;
Exclusion Criteria:
1. The pathology of the peritoneal nodule confirmed no metastasis, and the exfoliated cytology test was negative;
2. Pregnant or lactating women;
3. Suffer from severe mental illness;
4. Preoperative imaging or intraoperative exploration revealed that there have been distant blood metastases in the liver, lungs, and brain;
5. A history of other malignant diseases within 5 years;
6. A history of allergies to any component of teriprizumab, docetaxel, oxaliplatin, and fluorouracil;
7. A history of continuous systemic corticosteroid therapy within 1 month;
8. Complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
9. A history of unstable angina or myocardial infarction, or a history of cerebral infarction or cerebral hemorrhage within 6 months, and a lung function test FEV1 \<50% of the expected value;
10. Have received any of the following treatments:
1. Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past;
2. Have received any investigational drug treatment within 4 weeks before using the drug for the first time;
3. Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
4. Receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug;
5. Those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration;
6. Those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04886193
Study Brief:
Protocol Section:
NCT04886193