Holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: HEPAR Primary

Holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: HEPAR Primary - HEPAR Primary

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44682

Enrollment

Registered

2017-08-21

Start date

2017-12-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellulair carcinoma liver cancer

Interventions

166Ho-RE will be performed via a catheter during angiography.

Hepatocellular carcinoma

Holmium microspheres

Radioembolisation

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients must have given written informed consent. - Female or male aged 18 years and over. - Diagnosis of HCC established according to the Netherlands HCC guideline criteria (in line with American AASLD criteria): nodule >1 cm in a patient at risk for HCC, with combination of arterial hypervascularity and venous or delayed phase wash-out on multiphase CT-scan or MRI-scan. LR-5 and LR- 4 based on Liver Imaging Reporting and Data System (LIRADS) can be included based on discretion of the principal investigator. - No curative treatment options (resection, transplant, or in case of solitary tumor

Exclusion criteria

Exclusion criteria: - Evidence of significant extrahepatic disease (MRI-scan liver and multiphase abdominal CT as well as a thoracic CT are routinely performed at screening). - Radiation therapy within the last 4 weeks before the start of study therapy. - Previous or current treatment with RE. Previous treatment with TACE, surgery, RFA, and previous or current treatment with sorafenib are allowed. - Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy. - Serum bilirubin >34.2 micromole/L (2 mg/dL). - Glomerular filtration rate 1.5 in case of femoral approach (as opposed to radial). - Leukocytes 30 Gy, as calculated using scout dose SPECT/CT. - Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.

Design outcomes

Primary

Measure	Time frame
Safety, expressed as the rate of unacceptable toxicity.	—

Secondary

Measure	Time frame
* Tumor response. * Changes in tumor marker alpha-fetoprotein. * Quality of Life (QoL). * Biodistribution / Dosimetry. * Changes in hepatic function as determined by hepatobiliary scintigraphy.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)