NCT06609759招募中不适用
Efficacy and Safety of Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer: a Prospective, Observational Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 197
- 试验地点
- 5
- 主要终点
- 3-year Disease-Free Survival (DFS) rate
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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).
排除标准
- •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.
- •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.
- •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 study treatment 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 or trial compliance, including serious illnesses requiring treatment, severe laboratory abnormalities, or other social or family reasons.
研究组 & 干预措施
Standard chemotherapy regimen
干预措施: Standard chemotherapy regimen (Drug)
结局指标
主要结局
3-year Disease-Free Survival (DFS) rate
时间窗: 3-year after the last subject participating in
The 3-year DFS rate is defined as the percentage of patients who remain free of tumor recurrence or death within three years after surgery.
次要结局
- Rate of De-escalation Treatment(3-year after the last subject participating in)
- Disease-Free Survival (DFS)(3-year after the last subject participating in)
- Cumulative Risk of Recurrence(3-year after the last subject participating in)
- 3-year Overall Survival (OS) Rate(3-year after the last subject participating in)
研究者
Lian Liu, MD, PHD
Professor, Chief Physician
Qilu Hospital of Shandong University
研究点 (5)
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