DEBOXA for Inoperable NET Liver Metastases
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|ClinicalTrials.gov Identifier: NCT03881306|
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Neoplasm Metastasis Liver||Procedure: D-TACE using CalliSpheres and Oxaliplatin||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
Procedure: D-TACE using CalliSpheres and Oxaliplatin
D-TACE for NEN liver metastases Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
- Disease control rate (DCR) of intrahepatic lesions [ Time Frame: 2 years ]Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced CT or MRI scan according to RECIST criteria.
- Overall survival (OS) [ Time Frame: 30 month ]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.
- Progression Free Survival (PFS) [ Time Frame: 30 months ]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.
- Quality of life (QOL) [ Time Frame: 30 months ]Assessed according to EORTC QLQ-C30(V3.0)
- Side effects and adverse events [ Time Frame: 30 months ]To determine the safety and tolerability of DEBOXA for NEN liver metastases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881306
|Contact: Liangrong Shi, Ph.D||+86-13974886662 ext firstname.lastname@example.org|
|Contact: Weihua Liao, M.D.||8613974886662 ext email@example.com|
|Xiangya Hospital, Central South University||Recruiting|
|Changsha, Hunan, China, 410005|
|Contact: Liangrong Shi, M.D. 8613974886662 firstname.lastname@example.org|
|Principal Investigator:||Liangrong Shi, M.D.||Xiangya Hospital of Central South University|