Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma.
Megadott ok: The HOMIE-166 clinical investigation was prematurely terminated due to sponsor's decision to permanently stop production of QuiremSpheres™ and QuiremScouts™.
Key facts
- Where
- Augsburg és Munich, NémetországSee the 2 sites
Where in Németország
- Universitätsklinikum AugsburgAugsburg, NémetországNo longer taking part
- LMU KlinikumMunich, NémetországNo longer taking part
Trial details
- Who runs it
- Terumo Europe N.V.
- Trial code
- NCT05451862
- Record updated
- 2025. augusztus 26.
- Original description
166Ho-TARE is a promising modality for the treatment of HCC, given the unique characteristics of holmium, allowing careful patient selection and personalized dosimetry treatment planning. Further clinical evidence is needed to evaluate the safety and efficacy of 166Ho-TARE in the treatment of HCC patients with limited tumor burden, well preserved liver function and performance status and ineligible for liver transplantation and/or liver resection. This study will also provide further evidence on the dose-response relationship of 166Ho-TARE in (early) HCC.Read full original descriptionShow less
Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma; a Prospective, Single-arm, Open Label, Multicenter Phase II Study: HOMIE-166.
166Ho-TARE is a promising modality for the treatment of HCC, given the unique characteristics of holmium, allowing careful patient selection and personalized dosimetry treatment planning. Further clinical evidence is needed to evaluate the safety and efficacy of 166Ho-TARE in the treatment of HCC patients with limited tumor burden, well preserved liver function and performance status and ineligible for liver transplantation and/or liver resection. This study will also provide further evidence on the dose-response relationship of 166Ho-TARE in (early) HCC.
Inclusion: Age ≥ 18 years; Multidisciplinary tumor board decision for locoregional treatment; Freely given, written informed consent; Patients with unresectable HCC with a single nodule ≤ 8 cm or up to three nodules with a diameter of ≤ 5 cm (each) eligible for selective radioembolization (including position changes of infusion catheters); Non-cirrhotic patients or Child-Pugh A cirrhosis; ECOG performance status 0-1; Using an acceptable method of contraception throughout the study until survival follow up (for subjects of childbearing potential); Adequate hematological, renal and liver function; Adequate hematological function defined as:; Hemoglobin ≥ 6 mmol/L (9.7 g/dL); WBC ≥ 3.0 x 10E9/L; Absolute neutrophil count ≥ 1.5 x 10E9/L; Platelet count ≥ 50,000/mm3; Adequate renal function defined as:; Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN); Creatinine clearance ≥ 45 ml/min; Adequate liver function defined as:; Total bilirubin ≤ 35µmol/L (2.05 mg/dL); Albumin ≥ 30 g/L; AST and ALT ≤ 5X ULN.
Exclusion: Prior liver transplantation; Prior locoregional or systemic anti-cancer therapy for HCC and previous malignancies; Untreated active hepatitis B and/or C; Current or history of cancer other than HCC, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix; Diffuse and/or infiltrative HCC (defined as HCC consisting of multiple tiny liver nodules spreading throughout the entire liver or entire lobe, without a dominant nodule); Hypoperfused HCC (defined as a lack of tumor blush (i.e. reduced or no uptake of contrast fluid) observed on the intra-procedural CT); No full, selective arterial coverage on intra-procedural CT; Life expectancy < 6 months; Child-Pugh score ≥7 points; Macrovascular invasion (defined as macrovascular invasion of the hepatic and/or portal vein main branches); Extrahepatic metastases; Clinically significant ascites; Hepatic encephalopathy; Work-up imaging showing:; Lung shunt > 30 Gy is simulated on 166Ho-scout imaging; or; Uncorrectable extrahepatic deposition of simulated 166Ho-scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted; or; Anticipated ineffective tumor targeting (< 150 Gy mean tumor simulated absorbed dose) of 166Ho-scout for each lesion; or; Entire tumor burden not within the perfused liver volume (possible extrahepatic collateral supply of the tumor); or; Perfused liver volume > 50% of whole liver tissue; Pregnant or breast-feeding; In the Investigator's opinion there is a reason that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study; Concurrently enrolled in another study, unless it is an observational non-interventional study.