A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Combined With SOX and SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Mesylate Combined With SOX Regimen and SOX Regimen for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
详细描述
The aim of the study is to observe and evaluate the progression-free survival time (PFS), overall survival time (OS) and safety of patients with advanced Gallbladder Carcinoma treated with apatinib mesylate combined with SOX
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18 to 75
- •UICC/AJCC gallbladder TNM staging (The eighth edition), Ⅲ B - ⅣB (excluding M1) postoperative pathological diagnosis of gallbladder carcinoma;Patients confirmed to have undergone R1/R2 cholecystectomy or palliative surgery;
- •The primary treatment is surgical resection or potentially resectable cholecystic carcinoma without other treatment
- •ECOG performance status ≤1
- •The liver and kidney function meets the following conditions： BIL<3 normal value upper limit (ULN)；ALT and AST< 2.5 xULN;Serum Cr≤ 1xULN,Clearance rate of endogenous creatinine>50ml/min（Cockcroft-Gault）;
- •Other test rooms meet the following requirements:
- •Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days)；Neutrophilic granulocyte count > 1.5x109 /L;The platelet count ≥ 80 x 10 ^ 9/L;
- •Estimated life expectancy > 3 months.
- •Before the enrollment, the heart function is good. There is no episode of myocardial infarction within half a year. For example, if you have hypertension or coronary heart disease, you should ensure that it is within the controllable range.
- •Patient able and willing to provide written informed consent and to comply with the study protocol and Good compliance, with follow-up.
排除标准
- •Non gallbladder carcinoma
- •Significant clinical bleeding symptoms or a clear tendency to bleed occurred within the first month of randomization, such as cough/hemoptysis of 2.5ml or more, gastrointestinal bleeding, esophagogastric varices at risk of bleeding, hemorrhagic gastric ulcer, etc.
- •Other topical treatments during the study (including intraperitoneal chemotherapy, radiotherapy, etc.)
- •Pregnant or lactating women；
- •Those who suffer from high blood pressure and cannot be treated to the normal range by antihypertensive drugs；
- •HIV infection or the presence of AIDS-related diseases, or severe acute and chronic diseases;
- •Have grade II or higher myocardial ischemia or myocardial infarction、Poorly controlled arrhythmia；
- •Severe active infections；
- •There are secondary malignant tumors or other tumors within 3 years before the start of the study and there is metastasis of the brain or meninges.
- •Researchers believe that their compliance is poor
- •There are contraindications for Apatinib and S-1
研究组 & 干预措施
Apatinib with SOX(Tegafur,Oxaliplatin)
Patients 3-4 weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate
干预措施: Apatinib (Drug)
SOX( Tegafur,Oxaliplatin)
3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.
干预措施: Tegafur (Drug)
结局指标
主要结局
PFS
时间窗: 12 month after first treatment
progression-free survival
次要结局
未报告次要终点
研究者
Xiaoqing Jiang
Professor Chief Physician
Eastern Hepatobiliary Surgery Hospital