DEBOXA for Inoperable NET Liver Metastases

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiangya Hospital of Central South University
• Treatments: Oxaliplatin

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.