NCT03457844Unknown2 期
A Single Group, Open Label, Multi-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
To assess the primary effects and safety of Anlotinib in patients with Gastroenteropancreatic Neuroendocrine Tumor G3.
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
- •Patients should participate in the study voluntarily and sign informed consent;
- •18-75 years old;
- •Histopathological proven diagnosis of high grade (G3) advanced Gastroenteropancreatic Neuroendocrine Tumor(Unresectable locally advanced or distant Metastatic). the classification is based on the Ki-67 proliferative index >20%(WHO 2010),and Provision of qualified pathological tissue for central review;
- •Progression during or after treatment with first-line systematic chemotherapy;
- •At least one measurable nidus (by RECIST1.1);
- •Main organs function is normal;
- •Eastern Cooperative Oncology Group(ECOG) performance status(PS):0-1,Life expectancy of more than 12 weeks;
- •Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;
排除标准
- •Diagnosed with low or intermediate (G1,G2) neuroendocrine tumors, Manec, adenocarcinoma;
- •Functional neuroendocrine tumors(NETs) which need to be treated with long acting somatostatin analogue(SSAs) to control disease related syndromes, such as insulinoma, gastrinoma, glucagonoma, somatostatinoma, accompanied by carcinoid syndrome, Zollinger-Ellison syndrome or other active symptoms;
- •Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection；
- •Have received anti-vascular endothelial growth factor（VEGF）/VEGFR targeted drugs and progressed upon these drugs；
- •Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
- •Patients with any severe and/or unable to control diseases，including：
- •Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
- •Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
- •Patients with active or unable to control serious infections;
- •Patients with cirrhosis, decompensated liver disease, or active hepatitis;
- •Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
- •Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0g confirmed;
- •Patients had surgery (except biopsy) within 28 days or the surgical incision has not fully healed before the first study drug implementation;
- •Patients with brain metastasis or spinal cord compression which had not surgical and / or radiation therapy,or which had previous treatment but there is no clinical imaging evidence proving the condition is stable;
- •Anti-tumor therapy was performed within 4 weeks prior to initiation of the study treatment, including but not limited to chemotherapy, radical radiotherapy, bio-targeted therapy, immunotherapy, anti-tumor treatment of traditional Chinese medicine, hepatic artery embolization, hepatic metastatic cryoablation or radiofrequency ablation surgery.Palliative radiotherapy for a bone metastasis lesion within 2 weeks prior to the initiation of the investigational treatment;
- •The toxic reaction of previous anticancer treatment has not been restored to grade 0 or 1 (except hair loss);
- •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;
- •Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage;
- •Patients with drug abuse history and unable to get rid of or Patients with mental disorders;
- •Patients participated in other anticancer drug clinical trials within 4 weeks;
- •History of immunodeficiency;
- •Pregnancy(Positive detection of pregnancy before drug use)or lactation;
- •Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment;
研究组 & 干预措施
Anlotinib
Experimental
干预措施: Anlotinib (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: From randomization，each 42 days up to progressive disease(PD) or death(up to 24 months)
次要结局
- Overall survival(OS)(From randomization until death (up to 24 months))
- Objective Response Rate(ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Disease Control Rate(DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
研究者
研究点 (1)
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