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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03881306
Other study ID # NET11330
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2018
Est. completion date December 31, 2021

Study information

Verified date August 2020
Source Xiangya Hospital of Central South University
Contact Liangrong Shi, Ph.D
Phone +86-13974886662
Email shiliangr@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
D-TACE
D-TACE with CalliSpheres-Oxaliplatin

Locations

Country Name City State
China Xiangya Hospital, Central South University Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
Secondary 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. 30 month
Secondary 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. 30 months
Secondary Quality of life (QOL) Assessed according to EORTC QLQ-C30(V3.0) 30 months
Secondary Side effects and adverse events To determine the safety and tolerability of DEBOXA for NEN liver metastases 30 months
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