DEBOXA for Inoperable NET Liver Metastases

Central South University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Neuroendocrine Tumors

Neoplasm Metastasis

Liver

Treatments

Drug: D-TACE

Study type

Interventional

Funder types

Other

Identifiers

NCT03881306

NET11330

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.