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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07304258
Eligibility Criteria:
Inclusion Criteria:
1. Treatment-naïve patients who have not received chemotherapy, radiotherapy, or any other antitumor therapy prior to the start of the clinical trial;
2. Age between 18 and 75 years;
3. Male or non-pregnant, non-lactating female;
4. Gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathological diagnosis;
5. HER-2 negative by immunohistochemistry (IHC), and PD-L1 CPS ≥1;
6. Laparoscopic exploration confirming either positive cytology alone (P0CY1) or peritoneal metastasis (PCI score ≤10);
7. No other distant metastases;
8. Hematological criteria: white blood cell count ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L;
9. Biochemical criteria: ALT ≤2.5×ULN, AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;
10. Left ventricular ejection fraction ≥50%;
11. ECOG performance status 0-1;
12. Ability to comply with the study protocol and voluntarily provide signed informed consent.
Exclusion Criteria:
1. Inability to comply with the study protocol or procedures;
2. Known HER2-positive status;
3. Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types;
4. Current conditions or diseases affecting drug absorption;
5. Patients preoperatively confirmed as unsuitable for conversion therapy;
6. Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension;
7. Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth);
8. Known allergy to the investigational drug(s);
9. Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways;
10. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (HBV DNA ≥1×10⁴ copies/mL or \>2000 IU/mL despite prior antiviral therapy); Known primary immunodeficiency or active tuberculosis; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known history of human immunodeficiency virus (HIV) infection (HIV antibody positive);
11. Significant malnutrition (weight loss ≥5% within 1 month or \>15% within 3 months prior to informed consent, or food intake reduced by ≥50% within 1 week), unless corrected for ≥4 weeks before the first dose of investigational drug;
12. History of other primary malignancies, except:
* Malignancies in complete remission for at least 2 years prior to enrollment with no required treatment during the study;
* Adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of recurrence;
* Adequately treated carcinoma in situ with no evidence of recurrence;
13. Female patients who are pregnant or breastfeeding;
14. Any concomitant illness that, in the investigator's judgment, seriously endangers patient safety or affects study completion;
15. Patients deemed ineligible for the study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07304258
Study Brief:
Protocol Section:
NCT07304258