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New treatment option for Hepatocellular Carcinoma
Official title Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis
ClinicalTrials.gov ID: NCT06166576
What this study is testing
- What it's testing
- The RESOLVE trial, an open-label, single-arm, multi-center study, aims to assess the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres. This trial specifically targets patients diagnosed with hepatocellular carcinoma accompanied by localized portal vein tumor thrombosis (Vp1-Vp3) and who maintain good liver function.
- 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
- Adults aged 18 and over
- Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
- Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
- Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
- Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
You likely can't join if
- Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for...
- Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated...
- Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.
- Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.
- Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
- Patients scheduled to use immunotherapy regardless of the response to radioembolization.
See the full eligibility criteria
- Adults aged 18 and over
- Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
- Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
- Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
- Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
- Patients with no prior treatment for liver cancer
- Child-Pugh class A
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment
- Leukocytes ≥ 2,500/µL and ≤ 12,000/µL
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion)
- Total bilirubin ≤ 3.0 mg/dL
- Platelets ≥ 50,000/µL
- For patients not on anticoagulants, INR ≤ 2.0
- AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
- ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
- ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)
- Creatinine ≤ 2.0 mg/dL
- Patients with a life expectancy of more than 3 months
- Patients who have fully understood the clinical trial and given written consent
- Female patients of childbearing age confirmed not to be pregnant
- Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.
- Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated lung dose of 25 Gy.
- Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.
- Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.
- Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
- Patients scheduled to use immunotherapy regardless of the response to radioembolization.
- Patients who had active cancer within two years prior to joining the clinical trial.
- Patients who have undergone surgery or procedures related to the bile duct.
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Ilsan, Gyeonggi-do, South Korea
- Seoul, Seoul, South Korea
- Seoul, South Korea
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 Ilsan, Gyeonggi-do, South Korea; Seoul, Seoul, South Korea; Seoul, South Korea. 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.