Holmium-166 treatment for early stage liver cancer
Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma; a Prospective, Single-arm, Open Label, Multicenter Phase II Study: HOMIE-166.
This study is testing a new treatment using Holmium-166 for people with early-stage liver cancer that can't be surgically removed, to see if it is safe and effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Terumo Europe N.V. Industry-sponsored |
| Locations | 1 site (Munich) |
| Trial ID | NCT05451862 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Holmium-166 transarterial radioembolization (166Ho-TARE) in patients with unresectable hepatocellular carcinoma (HCC) who have limited tumor burden and well-preserved liver function. It is a prospective, single-arm, open-label, multicenter study that includes a scout dose of Holmium-166 microspheres to determine eligibility for the treatment. The primary endpoint will be assessed through blinded, independent central review by an imaging core laboratory, providing insights into the dose-response relationship of this innovative therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unresectable HCC, limited tumor burden, and well-preserved liver function.
Not a fit: Patients with advanced liver disease or those with cirrhosis beyond Child-Pugh A may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with early stage HCC who are not candidates for surgery.
How similar studies have performed: Previous studies have shown promise with similar radioembolization approaches, but the specific use of Holmium-166 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. Multidisciplinary tumor board decision for locoregional treatment
3. Freely given, written informed consent
4. 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)
5. Non-cirrhotic patients or Child-Pugh A cirrhosis
6. ECOG performance status 0-1
7. Using an acceptable method of contraception throughout the study until survival follow up (for subjects of childbearing potential)
8. 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 Criteria:
1. 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)
2. Hypoperfused HCC (defined as a lack of tumor blush (i.e. reduced or no uptake of contrast fluid) observed on the intra-procedural CT)
3. No full, selective arterial coverage on intra-procedural CT
4. Life expectancy \< 6 months
5. Child-Pugh score ≥7 points
6. Prior liver transplantation
7. Prior locoregional or systemic anti-cancer therapy for HCC and previous malignancies
8. Macrovascular invasion (defined as macrovascular invasion of the hepatic and/or portal vein main branches)
9. Extrahepatic metastases
10. Clinically significant ascites
11. Hepatic encephalopathy
12. Untreated active hepatitis B and/or C
13. 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
14. Pregnant or breast-feeding
15. Current or history of cancer other than HCC, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
16. 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
17. Concurrently enrolled in another study, unless it is an observational non-interventional study
Where this trial is running
Munich
- LMU Klinikum — Munich, Germany (Recruiting)
Study contacts
- Principal investigator: Jens Ricke, Prof. Dr. med — Ludwig-Maximilian-University Munich (LMU)
- Study coordinator: Florence Chow
- Email: florence.chow@terumo-europe.com
- Phone: +32(0)16 38 12 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.