Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Apr 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver a type of targeted treatment called radiolabeled somatostatin analogs to patients with neuroendocrine tumors (NETs) that have spread mainly to the liver. These tumors come from cells in the digestive system or pancreas. The study compares the usual method of giving this treatment through a vein (intravenous) to a new approach where the treatment is delivered directly into the artery that feeds the liver (intra-arterial hepatic infusion). The goal is to see if the new method helps the treatment reach the liver tumors better and if it is safe.

People who might be eligible for this trial are adults who have a well-diagnosed neuroendocrine tumor from the gastrointestinal tract or pancreas, with tumors mostly in the liver that cannot be removed by surgery. They must have already received a standard treatment called LUTATHERA® and still have active disease in the liver. Participants will need to have good kidney and liver function, a certain level of blood counts, and be in fairly good overall health. During the trial, patients will have imaging scans to compare how well the treatment reaches the tumors with the two methods, and they will receive the new way of treatment through the liver artery to check for safety and effectiveness. This trial is currently recruiting patients and aims to find better options for managing liver tumors in neuroendocrine cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP).
• • Patients are progressive after treatment with cold somatostatin analog (within 12 months according to RECIST), or as soon as the diagnosis is made in case of hepatic invasion \> 50% without waiting for tumour progression
• • Patient has received 4 standard of care LUTATHERA® cycles
• • Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the last cycle
• • ECOG performance status 0-2
• • 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
• • Age ≥ 18 years, no superior limit
• • Contraception required in pre-menopausal female (Intrauterine device, Progestin Pills, Combined Oral Contraceptives, Monthly Injectables, Progestin Injectables, Combined Patch, Combined Vaginal Ring, Female Sterilization, Vasectomy, Implants) and men for at least 6 months after the last LUTATHERA ® injection.
• • Patient´s signed written informed consent
• • Patient affiliated to a social security system
• Exclusion Criteria:
• • Patients with complete response defined by the absence of lesion according to RECIST 1.1 realized during morphological imaging at inclusion (chest-abdomen-pelvis CT scan and hepatic MRI)
• • No residual uptake according to standard 177-Lu scintigraphy performed in the clinical routine 24 hours after each LUTATHERA IV treatment
• • Carcinoid heart disease (LVEF \< 40%)
• • Dominant or threatening extrahepatic metastases or that may affect vital prognosis
• • Contraindications to intra-hepatic arterial infusion (coagulation disorders, portal thrombosis, intra-hepatic biliary tract dilatation, digestive or biliary anastomosis or fistula, cirrhosis (Child Pugh B8 or C...)
• • Serum albumin \<30 g/L unless prothrombin time is within the normal range.
• • 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.
• • Individuals under legal protection or unable of giving their informed consent
• • Pregnancy or breast feeding
• • Currently participating to another clinical research protocol
• • Individuals under legal protection or unable of giving their informed consent
• • MRI scan contraindicated
• • LUTATHERA® contraindicated or toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose