Neuroendocrine Tumors Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01218555 -
Study of Everolimus (RAD001) in Combination With Lenalidomide
|
Phase 1 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Recruiting |
NCT04614766 -
A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
| Completed |
NCT03273712 -
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
|
Phase 2 | |
| Recruiting |
NCT05636618 -
Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT03986593 -
Cryoablation of Bone Metastases From Endocrine Tumors
|
N/A | |
| Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
| Completed |
NCT02815969 -
The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
|
||
| Completed |
NCT02441062 -
Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT02174549 -
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02134639 -
PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
|
N/A | |
| Completed |
NCT02132468 -
A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers
|
Phase 2 | |
| Recruiting |
NCT01201096 -
Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE)
|
N/A | |
| Terminated |
NCT01163526 -
Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
|
N/A | |
| Completed |
NCT01099228 -
Combination Targeted Radiotherapy in Neuroendocrine Tumors
|
N/A | |
| Completed |
NCT00171873 -
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
|
Phase 3 | |
| Active, not recruiting |
NCT05077384 -
Open-label Study of Surufatinib in Japanese Patients
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04544098 -
Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver
|
Early Phase 1 | |
| Active, not recruiting |
NCT02736500 -
Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors
|
Phase 1/Phase 2 |