NCT05007093进行中（未招募）2 期
An Exploratory Study on Efficacy of Anlotinib Hydrochloride in the Treatment of Locally Advanced or Metastatic Differentiated Thyroid Cancer
Yansong Lin1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The changes in glucose metabolism
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of anlotinib in patients with locally advanced or metastatic differentiated thyroid cancer resistant to iodine therapy.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •locally advanced or metastatic RAIR-DTC (papillary, follicular [including Hürthle cell], and poorly differentiated) progressed within 18 months after the last treatment according to the Response Evaluation Criteria in Solid Tumors, version 1.1
- •Patients with RAIR-DTC should meet at least 1 of the following conditions: (a) the tumor invaded vital organs, cannot be completely removed nor suitable for further iodine treatment, or (b) lesions do not demonstrate iodine uptake on any radioactive iodine scan, or (c) received cumulative RAI activity ≥22.3 GBq (≥600 mCi), or (d) tumors retained iodine uptake but demonstrated radiological examination confirmed disease progression within 18 months after RAI treatment.
- •at least one measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •life expectancy of at least 6 months
- •adequate main organ function ((a) Hemoglobin (HBG) ≥ 90g/L, (b) neutrophil count (ANC) ≥ 1.5×109/L, (c) platelet count (PLT) ≥ 80×109/L, (d) total bilirubin < 1.5×ULN (upper limit of normal), (e) alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5×ULN, if accompanied by liver metastases, then ALT and AST ≤ 5 × ULN; (f) serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min; (g) left ventricular ejection fraction ≥ 50% of the normal level
- •Negative pregnancy test (serum or urine) within 7 days prior to enrollment for women of childbearing potential (subjects should use appropriate contraception until 6 months after the last dose)
排除标准
- •Patients who have received external radiotherapy or iodine-131 therapy in recent 3 months, or plan to receive other systemic anti-tumor therapy or anti-tumor therapy with traditional Chinese medicine during the study period.
- •Patients with other malignant tumors within 5 years or currently. Except primary cervical cancer, non-melanoma skin cancer and superficial bladder tumor.
- •The toxicity of CTCAE (4.0) above grade 1 was not alleviated, excluding patients with neurotoxicity (≤ grade 2) and alopecia caused by oxaliplatin.
- •With factors affecting oral administration (such as swallow, chronic diarrhea, etc.).
- •Patients with pleural effusion or ascites causing respiratory syndrome (CTCAE2 level above).
- •Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks.
- •Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
- •Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
研究组 & 干预措施
Anlotinib hydrochloride
Experimental
12 mg, 2 weeks on/ 1 week off, 21 days per cycle; treatment interruption or reduction (to 10 mg or 8 mg) was allowed
干预措施: Anlotinib hydrochloride (Drug)
结局指标
主要结局
The changes in glucose metabolism
时间窗: up to 24 months
Evaluated by maximum standard uptake value (SUVmax)
次要结局
- PFS(up to 24 months)
- Time to response (TTR)(up to 24 months)
研究者
Yansong Lin
Prof. M.D.
Peking Union Medical College Hospital
研究点 (1)
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