Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug safety.
详细描述
In locally advanced nasopharyngeal carcinoma(NPC), although radiotherapy and chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for metastatic NPC who failed to chemoradiotherapy therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib as maintenance therapy after chemoradiotherapy in nasopharyngeal carcinoma with metastasis.
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
- •Male and female patients aged ranging from 18 to 75 years old.
- •Naive or recurrent Nasopharyngeal Carcinoma with metastasis after chemotherapy or radiotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 -
- •Adequate hematologic (neutrophil count>=1.5×109/L, hemoglobin>=80g/L, platelets>=80×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x2, bilirubin level =< UNL x 1.5).
- •Adequate renal function (creatinine clearance ≥ 60 mL/min).
- •Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
排除标准
- •Previously, patients did receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib.
- •Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
- •Bleeding tendency or coagulation disorders.
- •with brain metastases.
- •Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- •Urine protein≥++, or urine protein in 24 hours≥1.0g
- •Severe uncured wounds, ulcers or fracture.
- •Pregnant or breast-feeding.
- •Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- •Patients have these symptoms, such as neurological diseases, mental illness, serious infection.
- •The researcher believe that the Patient is not suitable to participate in the study.
研究组 & 干预措施
apatinib
apatinib,500mg,qd，28 day/cycle until the emergence of PD, death, intolerable toxicity
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 12 months
The first day of treatment to the date that disease progression is reported
次要结局
- Overall survival(up to 24 months)
- Quality of Life (QoL) questionnaire(up to 24 months)
研究者
Mei Feng
Associate chief physician
Sichuan Cancer Hospital and Research Institute