DEBOXA for Inoperable NET Liver Metastases

Neuroendocrine Tumors Clinical Trial

Official title:

CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03881306
• Other study ID #: NET11330
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Liver
• Neoplasm Metastasis
• Neuroendocrine Tumors

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