DEBOXA for Inoperable NET Liver Metastases

• Sponsor: Xiangya Hospital of Central South University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03881306
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors; Neoplasm Metastasis; Liver	Drug: D-TACE	Phase 1/Phase 2

Detailed Description

OBJECTIVES:

1. 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.

2. Determine the response rate (RR) of intrahepatic lesions in patients treated with this regimen.

3. 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.

4. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial
• Actual Study Start Date: Jul 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: D-TACE D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin	Drug: D-TACE; D-TACE with CalliSpheres-Oxaliplatin; Other Names: CalliSpheres-Oxaliplatin

Outcome Measures

Primary Outcome Measures

1. Disease control rate (DCR) of intrahepatic lesions [2 years]

   Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced CT or MRI scan according to RECIST criteria.

Secondary Outcome Measures

1. Overall survival (OS) [30 month]

   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.

2. Progression Free Survival (PFS) [30 months]

   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.

3. Quality of life (QOL) [30 months]

   Assessed according to EORTC QLQ-C30(V3.0)

4. Side effects and adverse events [30 months]

   To determine the safety and tolerability of DEBOXA for NEN liver metastases

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiangya Hospital, Central South University	Changsha	Hunan	China	410005

Sponsors and Collaborators

• Xiangya Hospital of Central South University

Investigators

• Principal Investigator: Liangrong Shi, M.D., Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiangya Hospital of Central South University
• ClinicalTrials.gov Identifier: NCT03881306
• Other Study ID Numbers: NET11330
• First Posted: Mar 19, 2019
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiangya Hospital of Central South University: TACE; Oxaliplatin
• Additional relevant MeSH terms: Neoplasm Metastasis; Neuroendocrine Tumors; Oxaliplatin

Study Results

No Results Posted as of Aug 20, 2020