Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2018-07-01
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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D-TACE
D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
D-TACE
D-TACE with CalliSpheres-Oxaliplatin
Interventions
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D-TACE
D-TACE with CalliSpheres-Oxaliplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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Liangrong Shi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Locations
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Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NET11330
Identifier Type: -
Identifier Source: org_study_id
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