Back to resultsDEBOXA for Inoperable NET Liver Metastases
Primary Purpose
Neuroendocrine Tumors, Neoplasm Metastasis, Liver
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
D-TACE
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring TACE, Oxaliplatin
Eligibility 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.
Sites / Locations
- Xiangya Hospital, Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
D-TACE
Arm Description
D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Quality of life (QOL)
Assessed according to EORTC QLQ-C30(V3.0)
Side effects and adverse events
To determine the safety and tolerability of DEBOXA for NEN liver metastases
Full Information
NCT ID
NCT03881306
First Posted
March 17, 2019
Last Updated
August 18, 2020
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03881306
Brief Title
DEBOXA for Inoperable NET Liver Metastases
Official Title
CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors, Neoplasm Metastasis, Liver
Keywords
TACE, Oxaliplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D-TACE
Arm Type
Experimental
Arm Description
D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
D-TACE
Other Intervention Name(s)
CalliSpheres-Oxaliplatin
Intervention Description
D-TACE with CalliSpheres-Oxaliplatin
Primary Outcome Measure Information:
Title
Disease control rate (DCR) of intrahepatic lesions
Description
Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced CT or MRI scan according to RECIST criteria.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
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.
Time Frame
30 month
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
30 months
Title
Quality of life (QOL)
Description
Assessed according to EORTC QLQ-C30(V3.0)
Time Frame
30 months
Title
Side effects and adverse events
Description
To determine the safety and tolerability of DEBOXA for NEN liver metastases
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liangrong Shi, Ph.D
Phone
+86-13974886662
Ext
8613974886662
Email
shiliangr@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weihua Liao, M.D.
Phone
8613974886662
Ext
8613974886662
Email
owenliao@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangrong Shi, M.D.
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangrong Shi, M.D.
Phone
8613974886662
Email
shiliangr@126.com
12. IPD Sharing Statement
Learn more about this trial
DEBOXA for Inoperable NET Liver Metastases
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