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HEPAR Primary: Holmium-166-radioembolization in Hepatocellular Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT03379844
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
Dutch Cancer Society
Erasmus Medical Center
Quirem Medical B.V.
Information provided by (Responsible Party):
Marnix Lam, UMC Utrecht

Brief Summary:
Patients with hepatocellular carcinoma often die from intrahepatic disease since current treatment options are generally limited. Local treatment using holmium radioembolization could offer an effective treatment and a more personal approach than yttrium radioembolization (standard-of-care) as holmium has more imaging options.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Hepatocellular Carcinoma Non-resectable Device: Holmium-166 radioembolization Phase 2

Detailed Description:

Primary objective:

• To establish the safety and toxicity profile of holmium radioembolization in patients with hepatocellular carcinoma.

Secondary objectives:

  • To evaluate efficacy of holmium radioembolization in hepatocellular carcinoma without curative treatment options in a non-comparative phase II study.
  • To evaluate tumor marker response.
  • To evaluate Quality of Life (QoL).
  • To evaluate biodistribution / dosimetry.
  • To evaluate hepatic function.

Study design: Multi-center, interventional, treatment, non-randomized, open label, non-comparative, early phase II study. The study is a collaboration between UMC Utrecht and Erasmus MC Rotterdam. Recruitment and treatment of patients will take place in both centers.

Intervention: Holmium radioembolization will be performed via a catheter during angiography.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Holmium-166-radioembolization in Patients With Unresectable Hepatocellular Carcinoma (HCC); a Multi-center, Interventional, Non-randomized, Non-comparative, Open Label, Early Phase II Study: HEPAR Primary
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium

Arm Intervention/treatment
Experimental: Holmium-166 radioembolization Device: Holmium-166 radioembolization
An intra-arterial radioembolization procedure will be performed. The hepatic artery catheter is inserted via the femoral or radial artery under x-ray guidance by a trained interventional radiologist. The radiologist must repeatedly check the position of the catheter during the procedure to ensure it remains correctly sited and that reflux of the QuiremSpheres® into other organs does not occur. This is performed by injecting contrast medium. At the conclusion of the procedure, the catheter is removed.




Primary Outcome Measures :
  1. Safety, expressed as the rate of unacceptable toxicity. [ Time Frame: Up to 6 months ]
    Safety, expressed as the rate of unacceptable toxicity, which is the occurrence of RE-induced liver disease, defined as a total bilirubin increase grade 3 or higher according to the CTCAE version 4.03, in combination with ascites and low albumin, in the absence of disease progression


Secondary Outcome Measures :
  1. Tumor response based on radiologic assessment of MRI scans using mRECIST [ Time Frame: Up to 6 months ]
    Tumor response based on radiologic assessment of MRI scans using mRECIST

  2. Changes in tumor marker alpha-fetoprotein [ Time Frame: Up to 6 months ]
    Changes in tumor marker alpha-fetoprotein

  3. Quality of Life (QoL) using EORTC C30 [ Time Frame: Up to 6 months ]
    Quality of Life (QoL) using EORTC C30

  4. Quality of Life (QoL) using EORTC HCC18 [ Time Frame: Up to 6 months ]
    Quality of Life (QoL) using EORTC HCC18

  5. Quality of Life (QoL) using BPI-SF [ Time Frame: Up to 6 months ]
    Quality of Life (QoL) using BPI-SF

  6. Biodistribution/dosimetry based on quantitative assessment of MRI scans [ Time Frame: Up to 6 months ]
    Biodistribution/dosimetry based on quantitative assessment of MRI scans

  7. Changes in hepatic function as determined by hepatobiliary scintigraphy [ Time Frame: Up to 3 months ]
    Changes in hepatic function as determined by hepatobiliary scintigraphy



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
Criteria

Inclusion Criteria:

  • Patients must have given written informed consent.
  • Female or male aged 18 years and over.
  • Diagnosis of HCC established according to the Netherlands HCC guideline criteria (in line with American AASLD criteria): nodule >1 cm in a patient at risk for HCC, with combination of arterial hypervascularity and venous or delayed phase wash-out on multiphase CT-scan or MRI-scan.2, 4 LR-5 and LR- 4 based on Liver Imaging Reporting and Data System can be included based on discretion of the principal investigator.I
  • No curative treatment options (resection, transplant, or in case of solitary tumor <5 cm, RFA).
  • Life expectancy of at least 6 months.
  • ECOG Performance status 0-1 (Table 2).
  • Liver-dominant disease (maximum 5 lung nodules all ≤1.0 cm and mesenteric or portal lymph nodes all ≤2.0 cm are accepted).
  • Child-Pugh class A5-6 or B7.
  • At least one measurable liver lesion according to the modified RECIST criteria.21
  • Negative pregnancy test for women of childbearing potential. Female patients of child-bearing potential should use an highly effective acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) or should be more than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form), to prevent pregnancy.

Exclusion Criteria:

  • Evidence of significant extrahepatic disease (MRI-scan liver and multiphase abdominal CT as well as a thoracic CT are routinely performed at screening).
  • Radiation therapy within the last 4 weeks before the start of study therapy.
  • Previous or current treatment with RE. Previous treatment with TACE, surgery, RFA, and previous or current treatment with sorafenib are allowed.
  • Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
  • Serum bilirubin >34.2 micromole/L (2 mg/dL).
  • Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
  • Non-correctable INR >1.5 in case of femoral approach (as opposed to radial).
  • Leukocytes <2 109/l and/or platelet count <50 109/l.
  • Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
  • Pregnancy or breastfeeding.
  • Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression.
  • Patients who are declared incapacitated.
  • Previous enrollment in the present study.
  • Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner.
  • Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophago-gastro-duodenoscopy). In these cases, therapy with non-selective beta blocker (propranolol) or rubber band ligation should be instituted according to accepted guidelines. In case of small varices, prophylactic propranolol is advised.
  • Portal vein thrombosis (tumor and/or bland) of the main branch (diagnosed on contrast enhanced transaxial images). Involvement of the right or left portal vein branches and more distal is accepted.
  • Untreated active hepatitis. In case of detectable viral HBV load, treatment with a nucleos(t)ide analog such as entecavir or tenofovir should be instituted.
  • Transjugular intrahepatic portosystemic shunt (TIPS).
  • Body weight over 150 kg (because of maximum table load).
  • Severe allergy for intravenous contrast used (Visipaque®)(because of CT evaluation, pre-treatment angiography and treatment angiography).
  • Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
  • Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.

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): NCT03379844


Contacts
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Contact: Trial Office +31887551321 imaging_research@umcutrecht.nl

Locations
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Netherlands
Erasmus Medical Center Not yet recruiting
Rotterdam, Netherlands, 3015CN
Contact: Renée Leenaars    +31107033612    imaging.trialbureau@erasmusmc.nl   
Principal Investigator: Adriaan Moelker, MD, PhD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Tjitske Kent-Bosma    +31887551321    tbosma@umcutrecht.nl   
Principal Investigator: Marnix G. Lam, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
Dutch Cancer Society
Erasmus Medical Center
Quirem Medical B.V.
Investigators
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Principal Investigator: Marnix G. Lam, MD, PhD UMC Utrecht

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Responsible Party: Marnix Lam, Prof, UMC Utrecht
ClinicalTrials.gov Identifier: NCT03379844     History of Changes
Other Study ID Numbers: NL52338.041.17
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases