Angiotensin II for Liver cancer (primary or secondary)

Inclusion criteria

• {"criterion_text":"- Patients diagnosed with primary or metastatic liver tumors (any histological type)\n- Liver tumors with a tumor diameter ≥ 2 cm\n- Age ≥ 18 years\n- Written informed consent\n- A clinical indication for radioembolization\n- Competent and able to provide own informed consent (no legally designated representative)"}

Exclusion criteria

• {"criterion_text":"- Any serious comorbidity preventing the safe administration of AT-II. This includes uncontrolled hypertension or treatment with ≥3 antihypertensive drugs, arterial (cerebro-)vascular or venous thromboembolic event within the past 6 months\n- Known hypersensitivity to the active substance in Giapreza: angiotensin II\n- Known hypersensitivty to any of the excipients in Giapreza: mannitol, sodium hydroxide or hydrochloric acid\n- Known severe allergy for intravenous contrast fluids\n- Participation to another investigational study which may compromise any endpoint of the study\n- Any other significant comorbidity or medical condition that may compromise the safety of radioembolization\n- Any serious and/or chronic liver disease preventing the safe administration of radioembolization\n- Uncorrectable extrahepatic deposition of scout dose activity; activity in the falciform ligament, portal lymph nodes and gallbladder is accepted\n- Pregnancy or breastfeeding\n- Body weight over 150 kg (because of maximum table load)\n- Current use of angiotensin-converting enzyme inhibitors\n- Current use of angiotensin II receptor blockers (ARBs)\n- Known hypercoagulable state (i.e., thrombophilia)\n- History of severe peripheral vascular disease"}

Primary endpoints

• {"endpoint_text":"- TNR improvement factor: the TNR after AT-II infusion with subsequent direct 90Y microsphere injection as measured on 90Y PET/CT divided by the TNR after 99mTc-MAA without AT-II infusion as measured on SPECT/CT.","definition_or_measurement_approach":"TNR after AT-II infusion measured on 90Y PET/CT divided by TNR after 99mTc-MAA measured on SPECT/CT (i.e., the TNR improvement factor)."}

Secondary endpoints

• {"endpoint_text":"- Toxicity profile of combining 90Y radioembolization with AT-II infusion (graded according to CTCAE v5.0)","definition_or_measurement_approach":"Toxicity graded according to CTCAE v5.0."}
• {"endpoint_text":"- Technical success of AT-II infusion. Technical success is defined as the successful intra-arterial administration of AT-II (10 μg/min for 100 seconds) followed by immediate 90Y glass microsphere injection.","definition_or_measurement_approach":"Technical success = successful intra-arterial administration of AT-II at 10 μg/min for 100 seconds followed by immediate 90Y glass microsphere injection."}

Netherlands

Earliest CTIS Part Ii Submission Date

25-07-2025

Latest Decision Or Authorization Date

04-11-2025

Processing Time Days

102

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Universitair Medisch Centrum Utrecht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands