Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival (DFS)
研究概览
简要总结
The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.
详细描述
Gastric cancer is the second leading cause of cancer death worldwide. Highest incidence rate is observed in Eastern Asia.
D2 gastrectomy has been established as a standard surgical procedure. While recurrence rate after resection is still high.
The CLASSIC study showed that Xelox regimen after D2 gastrectomy improves 3-year disease-free survival compared with surgery only. But patients with late stage still have poor prognosis according to subgroup analysis and our retrospective study.
HER2 is an important biomarker and key driver of tumorigenesis in 7-34% gastric cancers. The ToGA study showed that trastuzumab, a monoclonal antibody that targets HER2, plus chemotherapy improved overall survival(16.0m vs 11.8m) in patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.
Based on previous experiences of trastuzumab in adjunctive therapy of breast cancer and ACTS/CLASSIC/ToGA studies, we suppose that trastuzumab plus XELOX as adjunctive treatment may benefit patients with HER2-positive Stage III gastric cancer after D2 Gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed informed-consent form.
- •Aged 18-80 years.
- •Had partial or total D2 gastrectomy and achieved R0 resection.
- •Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma
- •Pathologic Stage III (IIIA-C).
- •HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).
- •Patients must have received no preoperative chemotherapy or radiation therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .
- •Adequate liver/bone marrow function.Blood and biochemical parameters;
- •Compliant, and can be followed up regularly.
排除标准
- •Patients who do not meet the Inclusion Criteria.
- •Pregnant or breast-feeding female, or not willing to take contraception measures during study.
- •Serious infection requiring antibiotics intervention during recruitment.
- •Allergic to study drug or with metabolism disorder.
- •Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine carcinoma or others.
- •Uncontrolled brain metastasis or mental illness.
- •Organ transplant recipients (Autologous transplantation of bone marrow and peripheral stem cell transplantation included).
- •Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
- •With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled diabetes,hypertension,etc.
- •with other malignant tumors.
- •Can be followed up or obey protocol.
- •Ineligible by the discretion of the investigator.
研究组 & 干预措施
Trastuzumab,Capecitabine,Oxaliplatin
Patients receive eight 3-week cycles of oral capecitabine (800-1000 mg/m2 twice daily on days 1-14 of each cycle) ,intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) plus intravenous Trastuzumab (440mg on day 0 of each cycle).
Number of cycle:capecitabine and oxaliplatin --8 cycles; Trastuzumab--14-16 cycles.
干预措施: Trastuzumab (Drug)
Trastuzumab,Capecitabine,Oxaliplatin
Patients receive eight 3-week cycles of oral capecitabine (800-1000 mg/m2 twice daily on days 1-14 of each cycle) ,intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) plus intravenous Trastuzumab (440mg on day 0 of each cycle).
Number of cycle:capecitabine and oxaliplatin --8 cycles; Trastuzumab--14-16 cycles.
干预措施: Capecitabine (Drug)
Trastuzumab,Capecitabine,Oxaliplatin
Patients receive eight 3-week cycles of oral capecitabine (800-1000 mg/m2 twice daily on days 1-14 of each cycle) ,intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) plus intravenous Trastuzumab (440mg on day 0 of each cycle).
Number of cycle:capecitabine and oxaliplatin --8 cycles; Trastuzumab--14-16 cycles.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
3-year disease-free survival (DFS)
时间窗: Measure at every 6 weeks (every 2 cycles)
Defined as the time from study treatment to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause.
次要结局
- Overall survival(up to 3 years)
- Safety and tolerability(up to 18 month)
- Prognostic value of biomarkers(up to 3 years)
研究者
Dai, Guanghai
Professor and chief physician
Chinese PLA General Hospital