Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer (NCT06609759) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer
China197 participantsStarted 2024-01-01
Plain-language summary
For patients with stage II-III gastric cancer after radical D2 resection and R0 resection, postoperative adjuvant therapy guided by ctDNA-MRD (MRD-GATE external cohort) was not inferior to the standard chemotherapy regimen (this cohort).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
✓. No preoperative neoadjuvant or adjuvant therapy received.
✓. Voluntary participation with signed informed consent, demonstrating good compliance and 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 of normal. 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 criteria
✕. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy 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.
What they're measuring
1
3-year Disease-Free Survival (DFS) rate
Timeframe: 3-year after the last subject participating in
✕. History of other malignancies within the past five years, except certain skin cancers, 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 myocardial infarction within the last 12 months.
✕. Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.