A Exploratory Study of Apatinib in Combination With S1 in Patients With Advanced Gastric Evaluating the Efficacy and Safety
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial to investigate the safety and efficacy of apatinib combined with S1 after failure of first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma patients.
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, aged between 18 and 75 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- •Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;
- •Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
- •Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10*9/L, neutrophil ≥1.5 × 10*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);
- •Expected survival of ≥ 12 weeks.
排除标准
- •Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;
- •Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
- •Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
- •Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- •Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
- •With psychotropic drug abuse history and can't get rid of or mental disorder patients;
- •Associated with CNS (central nervous system) metastases;
- •Active bacterial infections;
- •Pregnant or breast-feeding women;
- •Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
研究组 & 干预措施
Apatinib plus S1
patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Approximately 1 year
defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 6 weeks of therapy
次要结局
- Overall survival (OS)(Approximately 2 years)
- Safety (incidence of adverse events)(Approximately 1 year)
- Quality of life(QoL)(Approximately 2 years)
研究者
Zhongtao Zhang
assistant dean, professor
Beijing Friendship Hospital