Ablative radioembolization for liver cancer with portal vein tumor thrombosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RESOLVE trial is an open-label, single-arm, multi-center study designed to evaluate the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres in patients with hepatocellular carcinoma and localized portal vein tumor thrombosis. Participants will receive a targeted dose exceeding 205 Gy to the tumor and will be monitored for two years to assess treatment outcomes and safety. This trial specifically focuses on patients with good liver function and no prior treatments for liver cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18 and over
2. Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
3. Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
4. Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
5. Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
6. Patients with no prior treatment for liver cancer
7. Child-Pugh class A
8. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
9. Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment

   1. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL
   2. Absolute neutrophil count ≥ 1,500/mm\^3
   3. Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion)
   4. Total bilirubin ≤ 3.0 mg/dL
   5. Platelets ≥ 50,000/µL
   6. For patients not on anticoagulants, INR ≤ 2.0
   7. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
   8. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
   9. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)
   10. Creatinine ≤ 2.0 mg/dL
10. Patients with a life expectancy of more than 3 months
11. Patients who have fully understood the clinical trial and given written consent
12. Female patients of childbearing age confirmed not to be pregnant

Exclusion Criteria:

1. Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.

   1. 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.
   2. Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.
2. Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.
3. Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
4. Patients scheduled to use immunotherapy regardless of the response to radioembolization.
5. Patients who had active cancer within two years prior to joining the clinical trial.
6. Patients who have undergone surgery or procedures related to the bile duct.
7. Pregnant or breastfeeding women.

Where it's running

• National Cancer Center
  Ilsan, Gyeonggi-do, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• Seoul National University Hospital
  Seoul, Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Jin Woo Choi, MD, PhD — Seoul National University Hospital
• Study coordinator: Jin Woo Choi, MD, PhD
• Email: jwchoi.med@snu.ac.kr
• Phone: +82-220722584

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.