QuiremSpheres Observational Study

Terumo Europe N.V.20 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver, Cancer of, Non-Resectable

Interventions

Selective Internal Radiation Therapy with QuiremSpheres®DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

UMC Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

Tumor response

1\. Tumor response in the liver • Tumor response in liver for overall population and each tumor type, assessed 3 months after SIRT has been completed as per routine practice following the corresponding guidelines for each tumor type (e.g. RECIST, mRECIST, EASL)

Time frame: 3 months

Safety

2\. Frequency and Severity of Adverse Events • Safety will be evaluated by monitoring and recording the grade 3, 4 and 5 adverse events (AE) and all adverse device effects (ADE) occurring during and after treatment throughout follow up of patients. Severity of adverse events will be rated following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Safety assessment will also be based on routine blood tests with an emphasis on the liver function parameters obtained at baseline, after the SIRT procedure and throughout the follow up period.

Time frame: 12 months

Secondary Outcomes

Time to progression in liver and overall

Time from SIRT procedure until progression in liver / overall progression

Time frame: 12 months

Progression free survival in liver and overall

Time from SIRT procedure until progression in liver / overall progression or death.

Time frame: 12 months

Overall survival rate

Time from SIRT procedure until death from any cause

Time frame: 12 months

Percentage of patients downstaged to surgery, transplantation or any local ablative therapy (RFA/MWA…)

Number of patients that after the SIRT procedure underwent a surgery or transplantation

Time frame: 12 months

Data from ClinicalTrials.gov

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