Clinical trial · Interventional
DEBOXA for Inoperable NET Liver Metastases
CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial
NCT03881306CI-TRIAL-00046716unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver | — | UNRESOLVED | — |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D-TACE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- D-TACE
- description
- D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
- interventionNames
- Drug: D-TACE
Primary outcomes (1)
- measure
- Disease control rate (DCR) of intrahepatic lesions
- timeFrame
- 2 years
- description
- Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced CT or MRI scan according to RECIST criteria.
Secondary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- 30 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.