DEBOXA for Inoperable NET Liver Metastases

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neuroendocrine Tumors, Neoplasm Metastasis, Liver

Intervention / Treatment
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* Drug: D-TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis is confirmed by biopsy or clinical data, primary site is resected or primary site is not resected but without risks of bleeding, obstruction in the near future. Failure of ≥ 1 system treatment, such as long-acting somatostatin or EP chemotherapy regimen. Standard surgical resection can not be performed because of extent liver involvement （liver involvement ≥ 2 lobes or ≥ 2 major vessels）, or patients who are not willing to accept surgical operation. Predicted survival >3 months. Child Pugh Score: ≤ 7 ECOG score for performance status: 0-1 Informed consensus is achieved. Exclusion Criteria: Metastases to other organs or sites besides liver. Prior TACE for liver tumors in 1 year. Obvious hepatic arterio-venous shunt or arterio-portal shunt. Prior or concurrent malignancy (Except basal carcinoma or squamous carcinoma of skin or carcinoma in situ of cervex uteri which has been cured). Platelet count < 50,000/mm^3 or white blood cell count <3,000 /mm^3 without hypersplenism. Creatinine greater than upper limit of normal (ULN) AST or AST > 5 times ULN Compromised coagulation: INR (International normalised ratio) >1.5, current anti-coagulation therapy or hemorrhagic disorders. History of severe diseases involving heart, kidney, marrow, lung or central neural system. Infection diseases which need antibiotics treatment before less than 1 month. Co-existing morbidity or social environment which may lead patients not to obey study protocol or threat patients' safety.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-TACE<br>D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin | Drug: D-TACE<br>* D-TACE with CalliSpheres-Oxaliplatin<br>* Other names: CalliSpheres-Oxaliplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 30 months | 
| Quality of life (QOL) | Assessed according to EORTC QLQ-C30(V3.0) | 30 months | 
| Side effects and adverse events | To determine the safety and tolerability of DEBOXA for NEN liver metastases | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TACE, Oxaliplatin