NCT06178198 Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma
| NCT ID | NCT06178198 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Seoul National University Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-11-08 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 18 and over. 2. Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5). 3. Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm. 4. Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI. 5. Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI. 6. Patients with no prior treatment for liver cancer. 7. Child-Pugh class A. 8. ECOG performance status of 1 or less. 9. Patients with no major organ dysfunction according to blood tests performed 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 (transfusion allowed to meet this criterion) 4. Total bilirubin ≤ 3.0 mg/dL 5. Platelet ≥ 50,000/µL 6. INR ≤ 2.0 for patients not taking anticoagulants 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 adequately understood the clinical trial and consented in writing. 12. Non-pregnant women of childbearing potential. Exclusion Criteria: 1. 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. 1. 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. 2. Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments. 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 scheduled to use immunotherapy irrespective of the response to radioembolization. 4. Patients who have had active cancer within the last two years prior to the clinical trial participation. 5. Patients who have undergone surgery or procedures related to the bile duct. 6. Women who are pregnant or breastfeeding.
Contact & Investigator
Jin Woo Choi, MD, PhD
STUDY CHAIR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT06178198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06178198 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06178198 currently recruiting?
Yes, NCT06178198 is actively recruiting participants. Contact the research team at jwchoi.med@snu.ac.kr for enrollment information.
Where is the NCT06178198 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06178198 clinical trial?
NCT06178198 is sponsored by Seoul National University Hospital. The principal investigator is Jin Woo Choi, MD, PhD at Seoul National University Hospital. The trial plans to enroll 30 participants.
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