NCT03654612Unknown1 期
A Single Arm,Open Clinical Study of Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies
China International Medical Foundation1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies.
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
- •Age ≥ 18 years old, male or female;
- •Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);
- •Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;
- •According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;
- •ECOG PS: 0-1 points;
- •Baseline blood and biochemical indicators meet the following criteria:
- •Hemoglobin ≥ 80g/L, Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥ 90×109/L, ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastases), Serum total bilirubin ≤ 1.5 times the normal upper limit, Serum creatinine ≤ 1.5 times the normal upper limit, Serum albumin ≥ 30g / L;
- •The expected survival period is ≥3 months;
- •Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.
- •Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.
排除标准
- •A person who has been confirmed to be allergic to apatinib and/or its excipients;
- •Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male > 450 ms, female > 470 ms) and grade I cardiac insufficiency; urine protein positive patients;
- •Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
- •Patients who have used apatinib or tigeo in the first line
- •abnormal blood coagulation (INR>1.5, APTT>1.5 ULN), with bleeding tendency;
- •Patients with central nervous system metastases;
- •Pregnant or lactating women;
- •Patients with other malignancies within 5 years;
- •Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
- •Patients who have participated in other drug clinical trials within 4 weeks;
- •Have received VEGFR inhibitors such as sorafenib and sunitinib;
- •According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study;
- •The investigator believes that it is not suitable for inclusion.
研究组 & 干预措施
Apatinib+S-1
Experimental
Patients with recurrent/metastatic head and neck malignancies received apatinib plus S-1 as second-line therapy.
干预措施: Apatinib (Drug)
结局指标
主要结局
PFS
时间窗: 40 months
Progression free survival
次要结局
- OS(40 months)
研究者
Ping Liu
Attending doctor in oncology
China International Medical Foundation
研究点 (1)
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