DEBOXA for Inoperable NET Liver Metastases
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Liver
- Neoplasm Metastasis
- Neuroendocrine Tumors
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 intra...
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.
Tracking Information
- NCT #
- NCT03881306
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Liangrong Shi, M.D. Xiangya Hospital of Central South University
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