Clinical trial NCT03881306: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine Tumors
Neoplasm Metastasis
Liver
Keywords: TACE
Oxaliplatin
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease control rate (DCR) of intrahepatic lesions
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 30 month
measure: Progression Free Survival (PFS)
timeFrame: 30 months
measure: Quality of life (QOL)
timeFrame: 30 months
measure: Side effects and adverse events
timeFrame: 30 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Liangrong Shi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: