Gastroenteropancreatic Neuroendocrine Tumor G3 Clinical Trial
Official title:
A Single Group, Open Label, Multi-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3
To assess the primary effects and safety of Anlotinib in patients with Gastroenteropancreatic Neuroendocrine Tumor G3.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | August 30, 2019 |
| Est. primary completion date | August 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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: 1. Blood pressure unable to be controlled ideally(systolic pressure=150 mmHg,diastolic pressure=100 mmHg); 2. 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); 3. Patients with active or unable to control serious infections; 4. Patients with cirrhosis, decompensated liver disease, or active hepatitis; 5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L) 6. 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; |
| Country | Name | City | State |
|---|---|---|---|
| China | Yihebali Chi | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival(PFS) | From randomization,each 42 days up to progressive disease(PD) or death(up to 24 months) | ||
| Secondary | Objective Response Rate(ORR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) | ||
| Secondary | Overall survival(OS) | From randomization until death (up to 24 months) | ||
| Secondary | Disease Control Rate(DCR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) |