NCT06313567招募中3 期
Metronomic Capecitabine as Adjuvant Therapy in Stage III Gastric Cancer: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 3 Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 722
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
- •Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences
- •R0 gastrectomy with D2 lymphadenectomy
- •ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
- •No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).
排除标准
- •History of chemotherapy, radiotherapy, immunotherapy or target therapy
- •Multiple primary tumors
- •Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
- •Unavailable for R0 resection and D2 lymph node dissection.
- •Patients with stage IV gastric cancer
研究组 & 干预措施
Metronomic capecitabine
Experimental
Low-dose capecitabine maintenance (500 mg/m2 body surface area twice daily for 1 year) after completion of standard adjuvant chemotherapy,
干预措施: Metronomic capecitabine group (Drug)
Standard therapy group
Active Comparator
Observation after completion of standard adjuvant chemotherapy,
干预措施: Observation (Other)
结局指标
主要结局
Disease-free survival
时间窗: 3-year
DFS
次要结局
- Overall survival(3-year)
- Side effects(1-year)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinomato Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal CarcinomaNCT05940441Eye & ENT Hospital of Fudan University74
Unknown
2 期
Capecitabine to Prevent Recurrence of Hepatocellular Carcinoma After Curative ResectionNeoplasm MetastasisHepatocellular CarcinomaNCT00561522Fudan University290
招募中
3 期
Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)Head and Neck Squamous Cell CarcinomaNCT05044117Sun Yat-sen University220
撤回
2 期
CAPEcitabine eXtension of Adjuvant Therapy for Pancreatic Adenocarcinoma: (CAPE-X)Pancreas CancerPancreas AdenocarcinomaNCT06110598Case Comprehensive Cancer Center
进行中（未招募）
3 期
Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal CarcinomaMaintenance TherapyNasopharyngeal CarcinomaNCT05869227XIANG YANQUN166