Neuroendocrine TumorsPhase 1/2NCT03881306
DEBOXA for Inoperable NET Liver Metastases
A Phase 1/2 study testing D-TACE in people with Neuroendocrine Tumors and Neoplasm Metastasis, run by Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuroendocrine Tumors, Neoplasm Metastasis, Liver
- What is being tested?
- D-TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410005
Liangrong Shi, M.D., 8613974886662, shiliangr@126.com
About this study
Official title: CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial
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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Neuroendocrine Tumors, Neoplasm Metastasis, Liver
- Being tested
- D-TACE
- Keywords
- TACE, Oxaliplatin
- Medical subject headings
- Neuroendocrine Tumors, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-TACEDrug
Also called CalliSpheres-Oxaliplatin
D-TACE with CalliSpheres-Oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| D-TACE | Experimental | D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin Receives: Drug: D-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 30 month
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.
Measured: 30 months
Quality of life (QOL)
Assessed according to EORTC QLQ-C30(V3.0)
Measured: 30 months
Side effects and adverse events
To determine the safety and tolerability of DEBOXA for NEN liver metastases
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Jul 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangrong Shi, M.D., Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881306
- Sponsor's protocol ID
- NET11330
- Status last verified
- Aug 2020
- First submitted
- 17 Mar 2019
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial
- ClinicalTrials.gov ID
- NCT03881306
- Acronym / sponsor ID
- NET11330
- Conditions
- Neuroendocrine Tumors, Neoplasm Metastasis, Liver
- Keywords
- TACE, Oxaliplatin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D-TACE | Experimental | Drug: D-TACED-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-TACEAlso: CalliSpheres-OxaliplatinD-TACE with CalliSpheres-Oxaliplatin | Drug | D-TACE |
Primary outcome
Disease control rate (DCR) of intrahepatic lesions
Time frame: 2 years
Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced CT or MRI scan according to RECIST criteria.
4 secondary outcomes
Overall survival (OS)
Time frame: 30 month
Progression Free Survival (PFS)
Time frame: 30 months
Quality of life (QOL)
Time frame: 30 months
Side effects and adverse events
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liangrong Shi, M.D. principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing D-TACE in people with Neuroendocrine Tumors and Neoplasm Metastasis, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangrong Shi, Ph.D (+86-13974886662 ext. 8613974886662, shiliangr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) of intrahepatic lesions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.