NCT02509806Unknown2 期
Apatinib as Maintenance Therapy After First-line Chemotherapy(DC for 4 Cycles) in Postoperative Recurrence/Metastasis Progressive Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of apatinib as maintenance therapy after first-line chemotherapy in Postoperative Recurrence / Metastasis Progressive Gastric Cancer.
详细描述
Eligible patients will receive apatinib treatment(500mg qd p.o. q28d) until until disease progression or intolerable toxicity or patients withdrawal of consent after 4 cycles of DC first-line chemotherapy or only DC first-line chemotherapy.
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
- •Age: 18 to75 years old;
- •Histologically proven progressive gastric cancer. All pts were received D2 gastrectomy and recurrence / metastasis occured;
- •Complete 4 cycles DC first-line chemotherapy and no and no disease progression occurred. DC: Docetaxel 60-85mg/m2 iv d1, Cisplatin 60-75mg/m2 iv d1, q21d;
- •ECOG PS of 0-1;
- •Major organ function has to meet the following criteria:
- •ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; Bilirubin <1.5 times the upper limit of normal (ULN); ALT and AST <2.5 × ULN; liver metastases, if any, the ALT and AST<5 × ULN;
- •An expected survival of ≥ 3 months;
- •Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall 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), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.
- •Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
排除标准
- •Confirmed that apatinib and/or its accessories allergy;
- •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 II cardiac dysfunction;
- •Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- •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;
- •Associated with CNS (central nervous system) metastases;
- •Pregnant or lactating women;
- •Pts with other malignant tumor within 5 years(except cured skin basal cell carcinoma and cervical carcinoma);
- •With psychotropic drug abuse history and can't get rid of or mental disorder patients;
- •Participated in other clinical trials within 4 weeks.
- •Pts received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib);
- •Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
- •Other conditions regimented at investigators' discretion.
研究组 & 干预措施
Apatinib Maintenance Therapy After First-line Chemotherapy
Experimental
Apatinib Mesylate Tablets 500 mg qd p.o. after DC First-line Chemotherapy (Docetaxel 60-85mg/m2 i.v. d1, Cisplatin 60-75mg/m2 i.v. d1, q21d）
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: An expected average of 12 weeks
次要结局
未报告次要终点
研究者
Qun Zhao
Principal Investgator
Hebei Medical University
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Apatinib as Maintenance Therapy After Adjuvant Chemotherapy in Progressive Gastric Cancer With Positive Exfoliative Cancer CellsGastric CancerNCT02510469Hebei Medical University48
Unknown
2 期
Maintenance Treatment of Apatinib in Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT03130270Guilin Medical University, China29
Unknown
3 期
Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric CancerGastric CancerNCT02537171The Affiliated Hospital of the Chinese Academy of Military Medical Sciences40
Unknown
2 期
Clinical Study of Apatinib as the Second-line Therapy in Malignant MelanomaMalignant MelanomaNCT03383237Henan Cancer Hospital20
Unknown
2 期
Apatinib as Second-line Treatment of Advanced Pancreatic CancerPancreatic NeoplasmsNCT02726854First Affiliated Hospital Xi'an Jiaotong University30