Study of TAE added on chemotherapy in patients with metastatic neuroendocrine tumors

JRCT ID: jRCT1061210015

Registered date:21/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastroenteropancreatic neuroendocrine neoplasms
• Date of first enrollment: 27/07/2021
• Target sample size: 18
• Study type: Interventional
• Intervention(s): Induction of everolimus at a dose of 10 mg once daily after TAE using with embosphere which contain embolic beads

Outcome(s)

• Primary Outcome: Progression-Free Survival

Secondary Outcome

1 Overall Survival
2 Response Rate
3 Disease Control Rate
4 Adverse Event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Patients who diagnosed with non-functionnal GEP-NEN of which grade was G1 confirmed pathologically
2 Patients with liver metastatic tumors who have no treatment history of TAE and chemotherapy
3 20 age old over
4 Patienst who have been fully informed consent
5 Regardless of gender
6 Less than 1 of performance status
7 Adequate hematologic and end-organ function

Exclude criteria

1 Tumor thrombus or thrombus in the main and/or first portal vein
2 Moderate or severe ascites
3 Severe arteriovenous shunt in the liver
4 Allergy for contrast media
5 Less than 30 mL/min of eGFR
6 Allergy for Everolimus, Sirolimus and Sirolimus derivatives
7 Allergy for gelatin
8 Prior treatment with mTOR inhibitor
9 Long treatment with corticosteroids or other immunostimulatory agents
10 Significant cardiovascular, infectious, diabate or plumonary disease
11 The participant has a fasting glycemic level of 1.5 ULN or higher at the start of the screening period
12 Patients who diagnosed as Interstitial pneumonia by CT
13 Being pregnant or possibly pregnant
14 Patients who judged as not suitable for chemotherapy
15 Patients who judged as inappropriate candidate by the chief medical examine

Related Information

• Primary Sponsor: Kato Hironari