Clinical trial NCT03563274: QuiremSpheres Observational Study
Official title: Observational, Multicenter Study to Further Confirm The Efficacy and Safety of QuiremSpheres® (Holmium-166 Microspheres) Selective Internal Radiation Therapy (SIRT) in Unresectable Liver Cancer Patients.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver, Cancer of, Non-Resectable
Keywords: Hepatocellular Carcinoma,Holmium-166,SIRT,QuiremSpheres®
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable primary liver cancer or unresectable metastases in the liver.

Brief summary: The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.

Detailed description: Liver tumors can be of primary (Hepatocellular Carcinoma, HCC) or metastatic (mainly from colorectal carcinoma, CRC) origin. Both HCC and CRC are common causes of death from cancer worldwide. The overall incidence of HCC and CRC remains high in developing countries and is steadily rising in most industrialized countries. Available treatment options depend on the size, number, and location of tumors, on liver status, overall performance status and comorbidities, on patency of portal vein and presence of extrahepatic metastatic disease. They include surgical (liver resection, liver transplantation), systemic (e.g. chemotherapy, immunotherapy), ablative (thermal ablation, chemical ablation) and intra-arterial (chemoembolization, radioembolization) modalities. Radioembolization, also known as Selective Internal Radiation Therapy (SIRT) with microspheres containing a radiation-emitting isotope (Yttrium-90 or Holmium-166) delivers localized radiation in the vasculature around liver tumors with relatively limited concurrent injury to the surrounding normal/healthy tissue. Yttrium-90 radioembolization is currently included in several guidelines (EASLEORTC, ESMO).

Eligibility criteria: Inclusion Criteria:

* Patient with diagnosis of primary liver tumor or metastases in the liver from other primary cancers, allocated to SIRT with QuiremSpheres® as decided by a multidisciplinary tumor board
* Patient is ≥ 18 years
* Patient has understood and signed written informed consent to data collection in the study

Exclusion Criteria:

* Patient's refusal
* Local practice guidelines prohibiting the patient to receive SIRT

Primary outcomes:
measure: Tumor response
timeFrame: 3 months
measure: Safety
timeFrame: 12 months
Secondary outcomes:
measure: Time to progression in liver and overall
timeFrame: 12 months
measure: Progression free survival in liver and overall
timeFrame: 12 months
measure: Overall survival rate
timeFrame: 12 months
measure: Percentage of patients downstaged to surgery, transplantation or any local ablative therapy (RFA/MWA…)
timeFrame: 12 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Chief Medical Officer at Terumo Europe
name: Dragica Paunovic, MD
role: STUDY_DIRECTOR
References: