DEBOXA for Inoperable NET Liver Metastases

August 18, 2020 updated by: Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410005
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-TACE
D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
Drug: D-TACE
D-TACE with CalliSpheres-Oxaliplatin
Other Names:
  • CalliSpheres-Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Liangrong Shi, M.D., Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 17, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NET11330

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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