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.
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 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.
Single group
Ablative radioembolization using Yttrium-90 resin microspheres
Procedure/SurgeryBased on 99mTc-MAA mapping, a partition model (multi-compartment MIRD) is employed to plan for a radiation dose of 400 (± 30%) to the tumor. If delivering this dose to the tumor is challenging due to lung dose limitations, the maximum feasible dose is administered to the tumor while maintaining the estimated lung dose below 15 Gy. While treating the entire tumor with a single high-dose radioembolization session is preferred, if necessary due to considerations like estimated lung dose, the treatment can be divided into two sessions, keeping the cumulative lung dose below 25 Gy. For any methods not covered in this discussion, refer to the SIR-Sphere user manual by Sirtex.
Objective response rate according to localized mRECIST
The number of patients with partial or complete response as the best local response divided by the total number of participants
Duration of response according to localized mRECIST
The time from first documentation of partial or complete response to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer treatment, whichever comes first
Objective response rate according to mRECIST.
Duration of response according to mRECIST
2-year restricted mean duration of response according to localized mRECIST and mRECIST
Complete response rate according to localized mRECIST and mRECIST
Pre-treatment dosimetry based on 99mTc-MAA SPECT-CT
Post-treatment dosimetry based on Y90 PET-CT
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