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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
D-TACE with CalliSpheres-Oxaliplatin
Xiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGDisease control rate (DCR) of intrahepatic lesions
Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced CT or MRI scan according to RECIST criteria.
Time frame: 2 years
Overall survival (OS)
From the date of first D-TACE to the date of death from any cause or to completion of trial, whichever comes first, up to 30 months.
Time frame: 30 month
Progression Free Survival (PFS)
From the date of first D-TACE to the date of documented disease progression, including progression of intrahepatic lesions and progression of extrahepatic lesions, or to completion of trial, whichever comes first, up to 30 months.
Time frame: 30 months
Quality of life (QOL)
Assessed according to EORTC QLQ-C30(V3.0)
Time frame: 30 months
Side effects and adverse events
To determine the safety and tolerability of DEBOXA for NEN liver metastases
Time frame: 30 months
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