OncoMatch/Clinical Trials/NCT04837885
Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
Is NCT04837885 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies LUTATHERA® by intra-arterial hepatic (IAH) for neuroendocrine tumor.
Treatment: LUTATHERA® by intra-arterial hepatic (IAH) — The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: somatostatin analog — progression within 12 months
progressive after treatment with cold somatostatin analog (within 12 months according to RECIST)
Must have received: radiolabeled somatostatin analog (LUTATHERA) — 4 standard of care cycles
Patient has received 4 standard of care LUTATHERA® cycles
Cannot have received: radiolabeled somatostatin analog (LUTATHERA)
Exception: toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose
LUTATHERA® contraindicated or toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose
Lab requirements
Blood counts
hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/ mm3, platelets ≥ 75.000/mm3, with no evidence of hematologic alteration after 4 LUTATHERA® cycles
Kidney function
creatinine clearance ≥ 50 mL/min
Liver function
ALT/AST ≤ 2,5x the upper limit of normal
Cardiac function
Carcinoid heart disease (LVEF < 40%) [excluded]; Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (≥ 160/95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months [excluded]
Adequate kidney and liver function: creatinine clearance ≥ 50 mL/min, ALT/AST ≤ 2,5x the upper limit of normal; With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/ mm3, platelets ≥ 75.000/mm3; Carcinoid heart disease (LVEF < 40%) [excluded]; Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (≥ 160/95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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