NCT03096184Unknown2 期
A Non-randomized Phase II Study of Apatinib Mesylate Tablets Plus Tegafur Gimeracil Oteracil Potassium Capsules in Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2016年12月23日最近更新:
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
- 38
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck. The primary purpose of this study is to evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically / cytologically confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of head and neck origin not amenable to curative intent therapy; both human papillomavirus (HPV)(+) and HPV(-) tumors are eligible; tumors (squamous histology) of unknown primary that are clearly related to the head and neck area are eligible
- •Presence of measurable lesions (RECIST V1.1)
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- •Platelets >= 100 x 10^9/L
- •Hemoglobin (Hb) > 9 g/dL
- •Total calcium (corrected for serum albumin) within normal limits
- •Magnesium >= the lower limit of normal for the institution
- •Potassium within normal limits for the institution
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 1.5 x normal range (or =< 3.0 x upper limit of normal [ULN] if liver metastases are present)
- •Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
- •Serum creatinine =< 1.5 x ULN or 24-hour clearance >= 50 mL/min
- •Serum amylase =< ULN
- •Serum lipase =< ULN
- •Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)
- •Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential
- •Signed informed consent
排除标准
- •Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
- •Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;
- •Patients who have had prior allergic reaction to Apatinib;
- •The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
- •Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
- •Patients undergoing therapy with other investigational agents.
- •Women who are pregnant or breastfeeding;
- •Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.
研究组 & 干预措施
Study Group
Experimental
Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment
干预措施: Apatinib Mesylate Tablets (Drug)
Study Group
Experimental
Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment
干预措施: Tegafur Gimeracil Oteracil Potassium Capsules (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 2 years
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Overall survival
时间窗: 2 years
from date of enrollment until date of first death from any cause, assessed up to 2 years
次要结局
- Acute toxicity profiles, graded according to the NCI CTCAE version 3.0(6 months)
研究者
Guopei Zhu
M.D.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
研究点 (1)
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