NCT03229096Unknown2 期
Apatinib Plus XELOX Regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer Patients With Lymph Node Metastasis
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer PatientsWith lymph node metastasis
详细描述
This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial evaluating the efficacy and safety of Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer Patients With lymph node metastasis
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, age ≥18 years.
- •Karnofsky score 70%.
- •Histologically confirmed adenocarcinoma of gastric cancer with Lauren classification Clinically diagnosed stage T2-T4aN+M0 according to CT/MRI scan.
- •At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1), that is one or more perigastric lymph note were greater than or equal to 1.5cm in diameter.
- •Laparoscopic exploration confirms no peritoneal metastasis and negative peritoneal lavage.
- •Physical condition and adequate organ function to ensure the success of abdominal surgery.
- •Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL. Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.Adequate renal function: Serum creatinine ≤ 1 x ULN, and serum albumin≥30g/L.
- •Life expectancy of more than 5 years without serious concomitant diseases.
- •Written (signed) informed consent.
- •Able to comply with study and follow-up procedures.
- •Consent to provide tissue sample.
排除标准
- •Pregnant or lactating women.
- •pregnancy tests before entering the group (in serum) of the childbearing age women were positive, or no pregnancy tests.
- •patients with distant metastases or local unresectable factors.
- •tumor stage considered as cT1 by imaging or ultrasound gastroscopy.
- •Patients who received prior anti-tumor therapy including cytotoxic chemotherapy, radiotherapy, hormonal therapy and immunotherapy.
- •History of other malignancies within the last 5 years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix.
- •History of significant neurological or mental disorder, including seizures or dementia, which may interfere compliance and sign of consent inform.
- •Unstable, persistent cardiac disease despite medicinal treatment; myocardial infarction within 12 months before the start of the trial.
- •Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management.
- •Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug absorption.
- •Patients who experienced GI bleeding within two weeks, or with high risk of bleeding.
- •Patients with symptomatic peripheral neuropathy NCI CTC version> 1.0 grade, except only the deficiency of Deep tendon reflex.
- •Organ transplant patient need immunosuppression treatment.
- •Active or uncontrolled severe infection or other severe and /or uncontrolled diseases
- •Patients with moderate or severe chronic kidney disease estimated glomerular filtration rate≤50 ml/min or serum creatinine ≥the upper limit of normal(ULN),
- •deficiency of dihydropyrimidine dehydrogenase (DPD)
- •Allergy to the drugs in this protocol
- •Less than 4 weeks from the last clinical trial.
研究组 & 干预措施
Apatinib plus XELOX
Experimental
Patients will be given the perioperative chemotherapy of Apatinib plus XELOX once recruited
干预措施: Apatinib plus XELOX (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 3 months
Both CR and PR according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](30 days)
- Pathological response rate (pRR)(30 days)
- 3-year disease free survival rate(3 years)
- 3-year overall survival rate(3 years)
研究者
研究点 (1)
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