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QuiremSpheres Observational Study (Hope166)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563274
Recruitment Status : Terminated (did not meet planned recruitment expectations with a slow recruitment rate)
First Posted : June 20, 2018
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.

Study Description
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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.

Condition or disease Intervention/treatment
Liver, Cancer of, Non-Resectable Device: Selective Internal Radiation Therapy with QuiremSpheres®

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).
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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.
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer Safety

Groups and Cohorts
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Intervention Details:
  • 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.
    Other Name: SIRT, Radioembolization

Outcome Measures
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Primary Outcome Measures :
  1. Tumor response [ Time Frame: 3 months ]

    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)


  2. Safety [ Time Frame: 12 months ]

    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.



Secondary Outcome Measures :
  1. Time to progression in liver and overall [ Time Frame: 12 months ]
    Time from SIRT procedure until progression in liver / overall progression

  2. Progression free survival in liver and overall [ Time Frame: 12 months ]
    Time from SIRT procedure until progression in liver / overall progression or death.

  3. Overall survival rate [ Time Frame: 12 months ]
    Time from SIRT procedure until death from any cause

  4. Percentage of patients downstaged to surgery, transplantation or any local ablative therapy (RFA/MWA…) [ Time Frame: 12 months ]
    Number of patients that after the SIRT procedure underwent a surgery or transplantation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with unresectable primary liver cancer or unresectable metastases in the liver.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563274


Locations
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Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
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Study Director: Dragica Paunovic, MD Chief Medical Officer at Terumo Europe
More Information
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Additional Information:

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Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT03563274    
Other Study ID Numbers: T131E1
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terumo Europe N.V.:
Hepatocellular Carcinoma,Holmium-166,SIRT,QuiremSpheres®
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases