Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma (NCT06178198) | Clinical Trial Compass
RecruitingPhase 2
Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma
South Korea30 participantsStarted 2023-11-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Objective response rate according to localized mRECIST
Timeframe: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
2
Duration of response according to localized mRECIST
Timeframe: Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)