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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
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Neoplasm Metastasis Liver Procedure: D-TACE using CalliSpheres and Oxaliplatin Phase 1 Phase 2

Detailed 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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Quality of life (QOL) [ Time Frame: 30 months ]
    Assessed according to EORTC QLQ-C30(V3.0)

  4. Side effects and adverse events [ Time Frame: 30 months ]
    To determine the safety and tolerability of DEBOXA for NEN liver metastases



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Liangrong Shi, Ph.D +86-13974886662 ext 8613974886662 shiliangr@126.com
Contact: Weihua Liao, M.D. 8613974886662 ext 8613974886662 owenliao@csu.edu.cn

Locations
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China, Hunan
Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410005
Contact: Liangrong Shi, M.D.    8613974886662    shiliangr@126.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Liangrong Shi, M.D. Xiangya Hospital of Central South University

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03881306     History of Changes
Other Study ID Numbers: NET11330
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangya Hospital of Central South University:
TACE
Oxaliplatin
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neuroendocrine Tumors
Neoplastic Processes
Neoplasms
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Oxaliplatin
Antineoplastic Agents