Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT05451862

Abgebrochen

HOMIE-166: Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma.

Interventionsstudie

Phase nicht angegeben

LMU Klinikum

Sponsor: Terumo

Zuletzt aktualisiert: 25. September 2023
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Gerät, Radiopharmazeutika

Erforderliche Mutationen

Keine

Studie gestartet

21. August 2023

Zuletzt vom Sponsor aktualisiert

25. September 2023

Voraussichtlicher Abschluss

1. Januar 2031

Studienkontakt

Name:Florence Chow

E-Mail:florence.chow@terumo-europe.com

Telefon:+32(0)16 38 12 11

Name:Rijk De Jong

E-Mail:rijk.dejong@terumo-europe.com

Telefon:+32(0)16 38 12 11

Eignung

Einschlusskriterien

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

Ausschlusskriterien

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

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Design-Details

ZuteilungN/A

InterventionsmodellSingle Group Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer73

Arme & Interventionen

Arme

Interventionen

Typ: Other

Beschreibung: Patients with unresectable HCC with a single nodule ≤ 8 cm or up to three nodules with a diameter of ≤ 5 cm (each). Those patients who fulfil the initial selection criteria will undergo a work-up procedure for further screening of 166Ho-TARE eligibility. If a patient is deemed eligible for 166Ho-TARE, the patient will be included in the study.

Interventionen:

Holmium-166 treatment
Holmium-166 work-up

Ergebnismessungen

Primäre Ergebnismessungen

confirmed Objective Response Rate (ORR) by localized mRECIST5 years

ORR is defined as the proportion of patients achieving either complete or partial tumor response during the study, as assessed by blinded central image review according to localized mRECIST

Sekundäre Ergebnismessungen

Best ORR based on localized mRECIST5 years

The number and percent of patients with a confirmed response

Best and confirmed ORR based on mRECIST5 years

The number and percent of patients with a confirmed response

Duration of Response (DoR) ≥ 6 months based on localized mRECIST and mRECIST5 years

The number and percent of patients with a DoR ≥ 6 months. DoR is measured from time of initial response until radiological progression. Radiological progression is determined by blinded central image review according to localized mRECIST and mRECIST.

Time to Progression (TTP)5 years

TTP defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to progression as per mRECIST

Progression-Free Survival (PFS)5 years

PFS defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to the date of radiological progression or death from any cause. Radiological progression is determined by blinded central image review according to mRECIST

hepatic Progression-Free Survival (hPFS)5 years

hPFS defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to the date of radiological progression in the liver or death from any cause. Radiological progression is determined by blinded central image review according to mRECIST

Liver transplantation rate5 years

The number and percent of patients receiving a liver transplant

Liver resection rate5 years

The number and percent of patients undergoing a liver resection

Overall survival (OS)5 years

The median overall survival time

Safety and toxicity by evaluating the number of adverse events and the number of patients with each event5 years

Adverse events classified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. (including clinical and laboratory toxicity)

Liver function during follow-up ALBI score5 years

ALBI score

Liver function during follow-up using MELD score5 years

MELD score

Liver function during follow-up using Child Pugh score5 years

Child Pugh score

Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans5 years

Correlation between scout and treatment for extrahepatic dose deposition, including lung shunt and digestive shunting of QuiremSpheresTM Holmium-166 Microspheres.

Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans5 years

Correlation between treatment-based absorbed dose (into the tumor and healthy liver) and clinical outcomes in terms of toxicity and efficacy (i.e. radiological response).

Assessment of dosimetry and biodistribution based on quantitative assessment of imaging scans5 years

Correlation between scout-based simulated absorbed dose (into the tumor and healthy liver) and the treatment based absorbed dose (into the tumor and healthy liver).

Quality of Life using EQ-5D-5L questionnaire1 year

Patient reported outcome using EQ-5D-5L questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

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Studienzentren

Diese Studie hat 1 Studienzentrum

LMU Klinikum

Munich, DE

Name:Jens Ricke, M.D.

Rekrutierend

Munich, DE

LMU Klinikum

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