Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-31 @ 11:21 AM
Study NCT ID:
NCT03881306
Status:
UNKNOWN
Last Update Posted:
2020-08-20
First Post:
2019-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DEBOXA for Inoperable NET Liver Metastases
Sponsor:
Xiangya Hospital of Central South University
Organization:
Study Overview
Official Title:
CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective clinical trial to study the safety and effectiveness of Transcatheter Artery Chemotherapy and Embolization (TACE) using CalliSpheres Drug-Eluting Beads with oxaliplatin (DEBOXA) in treating patients who have inoperable neuroendocrine neoplasm (NEN) liver metastases.
Detailed Description:
OBJECTIVES:
I. Determine the safety and effectiveness of Transcatheter Artery Chemotherapy and Embolization (TACE) using CalliSpheres Drug-Eluting Beads with oxaliplatin (DEBOXA) in patients with inoperable neuroendocrine neoplasm (NEN) liver metastases.
II. Determine the response rate (RR) of intrahepatic lesions in patients treated with this regimen.
III. Determine the overall survival (OS), progression-free survival time (DFS), time to hepatic progression (THP), and quality of life (QOL) in patients treated with this regimen.
IV. Safety assessment: adverse events (AEs) and severe adverse events(SAEs)
OUTLINE: This is a single-arm, multi-center, prospective study.
Patients receive D-TACE. Embolization agent: CalliSpheres Drug-Eluting Beads. Chemotherapy agent: oxaliplatin. Treatment repeats every 5 weeks in the absence of progression of hepatic lesions, or unacceptable toxicity.
I. Determine the safety and effectiveness of Transcatheter Artery Chemotherapy and Embolization (TACE) using CalliSpheres Drug-Eluting Beads with oxaliplatin (DEBOXA) in patients with inoperable neuroendocrine neoplasm (NEN) liver metastases.
II. Determine the response rate (RR) of intrahepatic lesions in patients treated with this regimen.
III. Determine the overall survival (OS), progression-free survival time (DFS), time to hepatic progression (THP), and quality of life (QOL) in patients treated with this regimen.
IV. Safety assessment: adverse events (AEs) and severe adverse events(SAEs)
OUTLINE: This is a single-arm, multi-center, prospective study.
Patients receive D-TACE. Embolization agent: CalliSpheres Drug-Eluting Beads. Chemotherapy agent: oxaliplatin. Treatment repeats every 5 weeks in the absence of progression of hepatic lesions, or unacceptable toxicity.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: