A Randomized, Controlled, Open-Label, Multi-center Clinical Study Comparing the Efficacy of Close Follow-Up Versus Adjuvant Chemotherapy in Patients With Stage IB-IIA Gastric or Gastroesophageal Junction Adenocarcinoma Following Radical Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS) difference among three study arms after curative resection for stage IB-IIA gastric/gastroesophageal junction adenocarcinoma
研究概览
简要总结
This study is a randomized, controlled, open-label, multicenter trial. Patients who underwent radical resection for stage IB-IIA gastric or gastroesophageal junction adenocarcinoma were enrolled and stratified into low-risk and high-risk groups based on the presence of lymph node metastasis, vascular invasion, or elevated preoperative tumor markers (CEA or CA19-9). Patients in the low-risk group were directly enrolled in follow-up observation, while those in the high-risk group were randomized 1:1 to either close follow-up or adjuvant chemotherapy. The primary endpoint of the study is the efficacy and safety of adjuvant chemotherapy following radical resection in patients with stage IB-IIA gastric or gastroesophageal junction adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Aged ≥18 years of either gender. 2.Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with an ECOG performance status score ≤
- •3.Pathologic TNM stage IB-IIA gastric or gastroesophageal junction adenocarcinoma, excluding T2N
- •4.Curative surgical resection of the primary tumor completed. 5.Laboratory test criteria as below:
- •Absolute neutrophil count (ANC) ≥1.5×10⁹/L without granulocyte colony-stimulating factor administration within the preceding 14 days;
- •Platelet count ≥100×10⁹/L without blood transfusion within the preceding 14 days;
- •Hemoglobin >9 g/dL without blood transfusion or erythropoietin administration within the preceding 14 days;
- •Total bilirubin ≤1.5×upper limit of normal (ULN);
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;
- •Serum creatinine ≤1.5×ULN and calculated creatinine clearance (Cockcroft-Gault formula) ≥60 mL/min;
- •Adequate coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
- •Cardiac biomarkers within normal range; isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable.
- •6.Voluntary participation and written informed consent obtained prior to study enrollment
排除标准
- •1. Other malignant tumors of the stomach.
- •Receipt of any anti-tumor therapy other than the chemotherapy specified in this protocol prior to screening or planned administration of such therapy during the trial (including radiotherapy, targeted therapy, immunotherapy, etc.).
- •3. Concurrent or prior malignancy at other anatomic sites, except for adequately treated carcinoma in situ of cervix, basal cell carcinoma of skin, or other malignancies surgically cured with no disease recurrence for at least 5 years.
- •4. Presence of any severe or uncontrolled systemic diseases as follows:
- •Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Grade ≥Ⅱ.
- •Resting electrocardiogram showing severe, symptomatic and refractory abnormalities in cardiac rhythm, conduction or morphology, including complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia or atrial fibrillation.
- •History of arterial thrombosis, embolism or ischemic events within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack.
- •Poorly controlled hypertension (systolic BP>140 mmHg, diastolic BP>90 mmHg).
- •History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to first study drug administration, or clinically active interstitial lung disease at screening.
- •Active pulmonary tuberculosis.
- •Active or uncontrolled infection requiring systemic treatment.
- •Clinically active diverticulitis, intra-abdominal abscess or gastrointestinal obstruction.
- •Hepatic diseases including liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
- •Poorly controlled diabetes mellitus (fasting blood glucose, FBG>10 mmol/L).
- •Urinalysis showing ≥2+ proteinuria confirmed by 24-hour urinary protein quantification>1.0 g.
- •Psychiatric disorders rendering the subject unable to comply with study treatment.
- •5. Current participation in another clinical trial or participation in any other clinical trial within the preceding 3 months.
- •6. Known hypersensitivity to any investigational drugs used in this study.
- •Subjects deemed ineligible for enrollment at the Investigator's discretion.
研究组 & 干预措施
Low-risk follow-up group (Control Group 1)
Patients receive follow-up only.
High-risk close follow-up group (Control Group 2)
High-risk close follow-up group (Control Group 2): Patients receive follow-up only.
High-risk adjuvant chemotherapy group (Experimental Group)
High-risk adjuvant chemotherapy group (Experimental Group): Oral administration of Tegafur Gimeracil Oteracil Potassium Capsules. Dosage:
Body surface area < 1.25 m²: 40 mg twice daily 1.25 m² ≤ Body surface area < 1.5 m²: 50 mg twice daily Body surface area ≥ 1.5 m²: 60 mg twice daily One treatment cycle consists of 14 consecutive days of medication followed by a 7-day drug holiday, for a total of 8 cycles.
干预措施: Tegafur Gimeracil Oteracil Potassium Capsules for oral administration (Drug)
结局指标
主要结局
Disease-Free Survival (DFS) difference among three study arms after curative resection for stage IB-IIA gastric/gastroesophageal junction adenocarcinoma
时间窗: From randomization until 5 years after the last enrolled subject completes follow-up (median follow-up duration ≥36 months)
次要结局
未报告次要终点