NCT02525237Unknown2 期
Apatinib in Combination With S-1 as First-Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Qingdao Municipal Hospital0 个研究点目标入组 30 人开始时间: 2015年8月最近更新:
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
- 30
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, aged ≥18 years;
- •Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease;
- •Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3;
- •No previous chemotherapy for advanced/metastatic disease 1) Prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study); 2) No previous targeted therapy; 3) For patients who can't tolerate first-line chemotherapy or refuse to accept chemotherapy, if they request to participate in this study, may receive apatinib monotherapy after consultation with the principal investigator in consideration of ethics.
- •Hematological, Biochemical and Organ Functions: HB ≥ 80 g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L, BIL < 1.5×ULN, ALT or AST < 2.5×ULN (or < 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min;
- •Life expectancy of more than 3 months;
- •Duration from operation is more than 4 weeks;
- •For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
- •Signed informed consent.
排除标准
- •Patients with poor-controlled arterial hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease, arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), and cardiac dysfunction greater than Class II;
- •Factors affecting the oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- •Patients with a clear tendency of gastrointestinal bleeding;
- •Abnormal coagulation function (INR > 1.5×ULN, APTT > 1.5×ULN), with tendency of bleed;
- •Pregnant or lactating women;
- •Other conditions regimented at investigators' discretion.
研究组 & 干预措施
Apatinib plus S-1
Experimental
Apatinib (500 mg qd p.o.) concomitantly with S-1 (40 mg/m2 qd days 1-14 q3w p.o.)
干预措施: Apatinib (Drug)
Apatinib plus S-1
Experimental
Apatinib (500 mg qd p.o.) concomitantly with S-1 (40 mg/m2 qd days 1-14 q3w p.o.)
干预措施: S-1 (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Event driven, an expected average of 8 months
Safety will be assessed by incidence of adverse events
时间窗: An expected average of 8 months
次要结局
- Objective response rate (ORR)(An expected average of 8 months)
- Disease control rate (DCR)(An expected average of 8 months)
- Overall survival (OS)(Event driven, an expected average of 24 months)
- Quality of life (QoL)(An expected average of 24 months)
研究者
Xiaochun Zhang
Chairman
Qingdao Municipal Hospital
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