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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

Tracking Information
First Submitted Date  ICMJE March 17, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DEBOXA for Inoperable NET Liver Metastases
Official Title  ICMJE CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuroendocrine Tumors
  • Neoplasm Metastasis
  • Liver
Intervention  ICMJE Procedure: D-TACE using CalliSpheres and Oxaliplatin
D-TACE for NEN liver metastases Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
Study Arms  ICMJE Experimental: Treatment
D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
Intervention: Procedure: D-TACE using CalliSpheres and Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liangrong Shi, Ph.D +86-13974886662 ext 8613974886662 shiliangr@126.com
Contact: Weihua Liao, M.D. 8613974886662 ext 8613974886662 owenliao@csu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881306
Other Study ID Numbers  ICMJE NET11330
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiangya Hospital of Central South University
Study Sponsor  ICMJE Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Liangrong Shi, M.D. Xiangya Hospital of Central South University
PRS Account Xiangya Hospital of Central South University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP