QuiremSpheres Observational Study

Liver, Cancer of, Non-Resectable Clinical Trial

— Hope166  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03563274
• Other study ID #: T131E1
• Status: Terminated
• Start date: June 21, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2021
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver, Cancer of, Non-Resectable

Intervention

Device:
• Selective Internal Radiation Therapy with QuiremSpheres®
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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months
Primary	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.	12 months
Secondary	Time to progression in liver and overall	Time from SIRT procedure until progression in liver / overall progression	12 months
Secondary	Progression free survival in liver and overall	Time from SIRT procedure until progression in liver / overall progression or death.	12 months
Secondary	Overall survival rate	Time from SIRT procedure until death from any cause	12 months
Secondary	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	12 months