Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeoul National University Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ablative radioembolization using Yttrium-90 resin microspheres

Treatment groups

30 Participants
are divided into 1 treatment group