Phase
Condition
Digestive System Neoplasms
Gastric Cancer
Stomach Cancer
Treatment
Standard chemotherapy regimen
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who have undergone D2 gastrectomy, achieved R0 resection, and arepathologically diagnosed with stage II-III gastric cancer.
No preoperative neoadjuvant or adjuvant therapy received.
Voluntary participation with signed informed consent, demonstrating good complianceand willingness to cooperate with follow-up procedures.
Age between 18-75 years, with no gender restrictions.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Estimated survival of 6 months or more.
Baseline hematological and biochemical parameters within specified limits: a.Hemoglobin ≥ 80g/L. b. Absolute neutrophil count ≥ 1.5×10^9/L. c. Platelet count ≥ 100×10^9/L. d. Aspartate or alanine aminotransferase ≤ 2.5 times the upper limit ofnormal. e. Alkaline phosphatase ≤ 2.5 times the upper limit of normal. f.Thyroid-stimulating hormone (TSH) ≤ 1 times the upper limit of normal (if abnormal,T3 and T4 levels must be normal).
Exclusion
Exclusion Criteria:
Pregnant or lactating women, or women of childbearing potential with a positivepregnancy test at baseline.
Evidence of postoperative recurrence or metastasis.
Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
Positive resection margins identified in postoperative pathology.
History of other malignancies within the past five years, except certain skincancers, superficial bladder cancer, in situ cervical or breast cancer.
Uncontrolled pleural effusion, pericardial effusion, or ascites.
Severe cardiovascular conditions such as symptomatic coronary artery disease,congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardialinfarction within the last 12 months.
Uncontrolled infection, severe kidney disease, or other significant concurrentdiseases.
Allergic reactions to study drugs.
Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
Administration of live attenuated vaccines within 4 weeks prior to the first studytreatment dose or plans to receive such vaccines during the study period.
Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
Positive for COVID-19 nucleic acid or antigen test.
Other conditions deemed by the investigator to potentially affect patient safety ortrial compliance, including serious illnesses requiring treatment, severe laboratoryabnormalities, or other social or family reasons.
Study Design
Connect with a study center
Jinan Central Hospital,
Jinan, Shandong
ChinaActive - Recruiting
Qilu Hospital of Shandong Univertisy
Jinan, Shandong 250012
ChinaActive - Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong 250012
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266000
ChinaActive - Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong 264000
ChinaActive - Recruiting

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