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New treatment option for Liver Cancer (Locally Advanced or Metastatic)
Official title Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose (RADIANT)
ClinicalTrials.gov ID: NCT07312292
What this study is testing
What is Angiotensin II (Giapreza®)?
Angiotensin II (Giapreza®) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for liver cancer (locally advanced or metastatic).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial will test whether a short infusion of a drug called angiotensin II (AT-II) can make a liver cancer treatment work better. The drug is given directly into the artery that supplies blood to the liver, right before a treatment called yttrium-90 (90Y) radioembolization.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients diagnosed with primary or metastatic liver tumors (any histological type).
- A clinical indication for radioembolization.
- Liver tumors with a diameter ≥ 2 cm.
- Age ≥ 18 years.
- Competent and able to provide own informed consent (no legally designated representative).
You likely can't join if
- Any serious comorbidity preventing the safe administration of angiotensin II (AT-II). This includes:
- Uncontrolled hypertension.
- Treatment with ≥ 3 antihypertensive drugs.
- Arterial (cerebro-)vascular or venous thromboembolic event within the past 6 months.
- Current use of angiotensin-converting enzyme (ACE) inhibitors.
- Current use of angiotensin II receptor blockers (ARBs).
See the full eligibility criteria
- Patients diagnosed with primary or metastatic liver tumors (any histological type).
- A clinical indication for radioembolization.
- Liver tumors with a diameter ≥ 2 cm.
- Age ≥ 18 years.
- Competent and able to provide own informed consent (no legally designated representative).
- Written informed consent.
- Any serious comorbidity preventing the safe administration of angiotensin II (AT-II). This includes:
- Uncontrolled hypertension.
- Treatment with ≥ 3 antihypertensive drugs.
- Arterial (cerebro-)vascular or venous thromboembolic event within the past 6 months.
- Current use of angiotensin-converting enzyme (ACE) inhibitors.
- Current use of angiotensin II receptor blockers (ARBs).
- Known hypercoagulable state (i.e., thrombophilia).
- History of severe peripheral vascular disease.
- Known hypersensitivity to the active substance in Giapreza: angiotensin II.
- Known hypersensitivity to any of the excipients in Giapreza: mannitol, sodium hydroxide or hydrochloric acid.
- Any serious and/or chronic liver disease preventing the safe administration of radioembolization.
- Uncorrectable extrahepatic deposition of scout dose activity; activity in the falciform ligament, portal lymph nodes, and gallbladder is accepted.
- Pregnancy or breastfeeding.
- Body weight over 150 kg (because of maximum table load).
- Known severe allergy to intravenous contrast fluids.
- Participation in another investigational study which may compromise any endpoint of the study.
- Any other significant comorbidity or medical condition that may compromise the safety of radioembolization.
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Utrecht, Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.