BridgeMD
New treatment option for Hepatocellular Carcinoma
Official title Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06178198
What this study is testing
- What it's testing
- The RESCUE trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of ablative radioembolization using Yttrium-90. This treatment is being investigated as a potential curative approach, as well as a bridging or downstaging strategy for surgery, in patients with large hepatocellular carcinoma (greater than 8 cm) 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 hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5).
- Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm.
- Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI.
- Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI.
You likely can't join if
- Patients who are not suitable for ablative radioembolization as indicated by pre-treatment testing with macro-aggregated albumin labeled with...
- Cases where the estimated lung dose exceeds 15 Gy when 150 Gy of absorbed dose is administered to the tumor based on the partition method.
- Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments.
- 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 scheduled to use immunotherapy irrespective of the response to radioembolization.
- Patients who have had active cancer within the last two years prior to the clinical trial participation.
See the full eligibility criteria
- Adults aged 18 and over.
- Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5).
- Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm.
- Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI.
- Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI.
- Patients with no prior treatment for liver cancer.
- Child-Pugh class A.
- ECOG performance status of 1 or less.
- Patients with no major organ dysfunction according to blood tests performed 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 (transfusion allowed to meet this criterion)
- Total bilirubin ≤ 3.0 mg/dL
- Platelet ≥ 50,000/µL
- INR ≤ 2.0 for patients not taking anticoagulants
- 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 adequately understood the clinical trial and consented in writing.
- Non-pregnant women of childbearing potential.
- Patients who are not suitable for ablative radioembolization as indicated by pre-treatment testing with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.
- Cases where the estimated lung dose exceeds 15 Gy when 150 Gy of absorbed dose is administered to the tumor based on the partition method.
- Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments.
- 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 scheduled to use immunotherapy irrespective of the response to radioembolization.
- Patients who have had active cancer within the last two years prior to the clinical trial participation.
- Patients who have undergone surgery or procedures related to the bile duct.
- Women who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, 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 Seoul, 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.