Hope166: QuiremSpheres Observational Study

• Sponsor: Terumo Europe N.V. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03563274
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Actual Duration (Months): 25.3
• Patients Per Site: 10
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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: Jun 21, 2018
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Jul 31, 2020

Outcome Measures

Primary Outcome Measures

1. Tumor response [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 [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 [12 months]

   Time from SIRT procedure until progression in liver / overall progression

2. Progression free survival in liver and overall [12 months]

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

3. Overall survival rate [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…) [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Carl Gustav Carus	Dresden		Germany	01307
2	UMC Utrecht	Utrecht		Netherlands	3508 GA

Sponsors and Collaborators

• Terumo Europe N.V.

Investigators

• Study Director: Dragica Paunovic, MD, Chief Medical Officer at Terumo Europe

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Terumo Europe N.V.
• ClinicalTrials.gov Identifier: NCT03563274
• Other Study ID Numbers: T131E1
• First Posted: Jun 20, 2018
• Last Update Posted: Mar 29, 2021
• Last Verified: Mar 1, 2021

• 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: Liver Neoplasms

Study Results

No Results Posted as of Mar 29, 2021