NCT02179463Unknown不适用
A Multicenter Clinical Registry to Compare Different Patterns of Response Evaluation to Neoadjuvant Chemotherapy for Gastric Cancer
Peking University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pathological Response
研究概览
简要总结
RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric cancer, yet the best pattern of response evaluation remain unknown.
PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.
详细描述
OBJECTIVES: I. Find the best pattern for response evaluation for gastric cancer. II. Assess the factor associated with this pattern.
OUTLINE: Neoadjuvant chemotherapy.
PROJECTED ACCRUAL: Up to 150 patients will be accrued over approximately 2 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sign written informed consent form
- •age ≥ 18 years
- •pathologically confirmed gastric or GEJ adenocarcinoma
- •disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0)
- •No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
- •Adequate organ function as defined below:
- •Hematologic ANC ≥ 1.5*109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100*109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN Renal Serum Creatinine < 1.5 ULN
- •Adequate lung and heart function
- •Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women
- •Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
排除标准
- •Refuse to provide blood/tissue sample；
- •With distant metastasis diagnosed by CT/EUS；
- •Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
- •History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）；
- •Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
- •Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
- •Concurrent severe infection；
- •Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)；
- •History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
- •Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
- •Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons.
结局指标
主要结局
Pathological Response
时间窗: 7days
次要结局
- downstage proportion(7days)
研究者
Jiafu Ji
Professor
Peking University
研究点 (1)
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