Status:
UNKNOWN
A Study of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Gastroenteropancreatic Neuroendocrine Tumor G3
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To assess the primary effects and safety of Anlotinib in patients with Gastroenteropancreatic Neuroendocrine Tumor G3.
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03457844
Start Date
January 30 2018
End Date
August 30 2019
Last Update
September 11 2018
Active Locations (1)
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1
Yihebali Chi
Beijing, Beijing Municipality, China, 100021