NCT03881306

DEBOXA for Inoperable NET Liver Metastases

CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroendocrine Tumors
• Neoplasm Metastasis
• Liver

Interventions

Type	Name	Description
DRUG	D-TACE	D-TACE with CalliSpheres-Oxaliplatin

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2019-03-19
• Last updated: 2020-08-20

Locations

1 site across 1 country: China