NCT03192735进行中（未招募）2 期
Apatinib Combined With Oxaliplatin and Gimeracil and Oteracil Porassium Capsules Neoadjuvant Therapy for Locally Advanced Gastric Cance: A Multicentre, One-armed, Clinical Pilot Trial
Chang-Ming Huang, Prof.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9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
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Radical surgical resection rate
研究概览
简要总结
We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)
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
- •Age from 18 to 75 years
- •Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- •cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- •No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- •Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
- •Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
- •Estimate life is equal or greater than 3 months
- •No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection
- •The main organ function is normal,and meet the following criteria:
- •blood routine examination( No blood transfusion within 14 days)
- •WBC≥3.5×109/L
- •ANC≥1.5×109/L，
- •PLT≥100×109/L；
- •blood biochemical examination
- •BIL <1.5 Upper Limit Of Normal（ULN），
- •ALT and AST<2.5ULN，GPT≤1.5×ULT；
- •Cr≤1ULN，creatinine clearance>60ml/min（Cockcroft-Gault formula）
- •Written informed consent
排除标准
- •Pregnant and lactating women
- •Suffering from severe mental disorder
- •History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- •History of previous chemotherapy or radiotherapy therapy
- •History of other malignant disease within the past 5 years
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of unstable angina or myocardial infarction within the past 6 months
- •History of cerebrovascular accident within the past 6 months
- •History of continuous systematic administration of corticosteroids within 1 month
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •Patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),The history of hematemesis and melena within 2 months,coagulation disorders(INR>1.5、APTT>1.5 ULN).
- •Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g)
- •There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction
- •Drug allergy to experimental medicine
研究组 & 干预措施
Apatinib Combined With SOX
Experimental
In this group,subject will be given ApatinibMesylateTablets 500mg one time a day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 one time a day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.
干预措施: ApatinibMesylateTablets (Drug)
结局指标
主要结局
Radical surgical resection rate
时间窗: 30 days
Radical surgical resection rate is defined as the rate of R0 resection
次要结局
- Pathological response rate(30 days)
- 5-year disease free survival rate(60months)
- overall postoperative morbidity rates(30 days)
- overall response rate(30 days)
- 30 days mortality rates(30 days)
- 5-year overall survival rate(60 months)
- Duration of postoperative hospital stay(30 days)
- adverse event(60 months)
研究者
Chang-Ming Huang, Prof.
Principal Investigator
Fujian Medical University
研究点 (1)
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