NCT03881306

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

2.5 years

First QC Date

March 17, 2019

Last Update Submit

August 18, 2020

Conditions

Neuroendocrine TumorsNeoplasm MetastasisLiver

Keywords

TACEOxaliplatin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Overall survival (OS)

    30 month

  • Progression Free Survival (PFS)

    30 months

  • Quality of life (QOL)

    30 months

  • Side effects and adverse events

    30 months

Study Arms (1)

D-TACE

EXPERIMENTAL

D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin

Drug: D-TACE

Interventions

D-TACEDRUG

D-TACE with CalliSpheres-Oxaliplatin

Also known as: CalliSpheres-Oxaliplatin
D-TACE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410005, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine TumorsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Liangrong Shi, M.D.

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangrong Shi, Ph.D

CONTACT

+86-13974886662shiliangr@126.com

Weihua Liao, M.D.

CONTACT

8613974886662owenliao@csu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 19, 2019

Study Start

July 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations

CN(1)