A Study Of Anlotinib In Patients With Gastroenteropancreatic Neuroendocrine Tumor G3

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-02-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-09-07
First Submitted that Met QC Criteria 2018-03-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-09-11
First Posted (ACTUAL) 2018-03-08	Results First Posted N/A	Last Verified 2018-03

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Anlotinib	DRUG: Anlotinib Anlotinib is followed Day 1 to day 14 by 7 days off treatment in a 21-day cycle） and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Anlotinib

DRUG: Anlotinib

Anlotinib is followed Day 1 to day 14 by 7 days off treatment in a 21-day cycle） and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measures	Measure Description	Time Frame
Progression Free Survival(PFS)		From randomization，each 42 days up to progressive disease(PD) or death(up to 24 months)

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate(ORR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Overall survival(OS)		From randomization until death (up to 24 months)
Disease Control Rate(DCR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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;

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：

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;

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

PatientS

Caregivers

Clinical Trial Record