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Hepatocellular CarcinomaPROACTIFNCT04069468

Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)

An observational study of Hepatocellular Carcinoma, run by Boston Scientific Corporation at 37 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
TheraSphere
Type of treatment
Medical device
How many people
1,247 participants
Where
37 sitesFrance
Study dates
13 Mar 2019to 31 Dec 2024
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All participants for whom treatment with TheraSphere® has been prescribed and reimbursed in France will be eligible for this study. It is estimated that data from >500 participants will be entered into this registry from approximately 30 sites in France.

Who may be able to join

  • Participant has received a reimbursed dose of TheraSphere®
  • Participant does not oppose to the collection of his/her medical personal data

Who cannot join

  • Participant has opposed to data collection
  • Participant has not received a reimbursed dose of TheraSphere® (free of charge dose)

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • CHU Amiens

    Amiens

  • CHU, Angers

    Angers

  • CHU Jean Minjoz

    Besançon

  • Institut Bergonié

    Bordeaux, 33000

  • Hôpital Haut Leveque

    Bordeaux

  • Centre Hospitalier Régional et Universitaire de Brest

    Brest, 29609

  • Hôpital Henri Mondor

    Créteil, 76038

  • Centre George-Francois Leclerc

    Dijon

  • CHU Dijon Bourgogne

    Dijon

  • CHU Michallon

    Grenoble

  • Bicêtre Hôpital

    Le Kremlin-Bicêtre, 94275

  • CHU Lille

    Lille

  • Centre Leon Berard

    Lyon

  • Hopital de la Croix-Rousse

    Lyon

  • Hopital Edouard Herriot

    Lyon

  • CHU de la Timone

    Marseille

  • Institut Paoli Calmettes

    Marseille

  • CHU Saint Eloi

    Montpellier

  • CHU Brabois Adultes

    Nancy

  • CHU Site Hotel Dieu

    Nantes

  • CHU de l'Archet

    Nice

  • CHU de Nîmes, Hôpital Carremeau

    Nîmes

  • Hopital Beaujon

    Paris

  • Hôpital Cochin, APHP

    Paris

  • Hôpital Saint-Louis

    Paris

  • Centre Hospitalier de Perpignan

    Perpignan, 66046

  • Hopital Lyon Sud

    Pierre-Bénite

  • CHU La Milétrie

    Poitiers

  • Centre Eugene Marquis

    Rennes

  • Centre Henri Becquerel

    Rouen

  • CHU Rouen

    Rouen

  • Centre Hospitalier Universitaire de St Etienne

    Saint-Priest-en-Jarez

  • CHU deHautepierre

    Strasbourg

  • Nouvel Hopital Civil

    Strasbourg

  • CHU Rangueil

    Toulouse

  • Hopital Paul Brousse

    Villejuif, 94800

  • Intstitut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Prospective, Post Approval, Multiple Centre, Open-Label, Non-Interventional, Registry Study to Evaluate Effectiveness of TheraSphere® in Clinical Practice in France

The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in France.

Read the detailed description

TheraSphere is a radioembolic therapeutic device used in the treatment of liver cancers. The goal of the registry study is to collect prospectively: participant description, treatment goal, treatment description, treatment results, safety, quality of life and survival data to ultimately demonstrate that TheraSphere treatment meets the claims that led to the reimbursement in France. The registry study is also an opportunity to improve the proper use of the device by team training especially for the personalized dosimetry treatment approach.

Clinical data will be collected and held in a secured, validated system and can be downloaded by Biocomplatibles UK Ltd Data Management on an ongoing basis. Data verification will be performed by Biocompatibles UK Ltd Data Management and data validation checks will be created by the validated data system (with the Biocompatibles UK Ltd team performing User Acceptance Testing on them before they go live). Adverse Events and concomitant diseases will be coded according to the version of Medical Dictionary for Regulatory Activities (MedDRA) agreed with Biocompatibles UK Ltd. Concomitant medications will be coded using the version of the World Health Organisation (WHO) Drug dictionary agreed with the validated data system.

Appropriate study plans implemented to manage all aspects of the trial to ensure quality and integrity of the data collection.

Being tested
TheraSphere
Keywords
Prospective Registry, TheraSphere®, France, SIRT, Liver Cancer, Adult, Liver Cell Carcinoma, Hepatoma, Intra arterial treatment, Intra hepatic Cholangiocarcinoma, Colon cancer metastasis
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TheraSphereDevice

    Also called Yttrium-90 Glass Microspheres

    Participants will receive treatment with TheraSphere in accordance with Instructions for Use

Study groups in NCT04069468
Study groupRoleWhat they receive
TheraSphere®Patients with HCC, iCC and mCRC will be treated. TheraSphere is administered in the liver through the hepatic artery. Treatment will be performed according to the Instructions for Use (IFU). Activity of administered TheraSphere is tailored in order to deliver an absorbed dose of 80 to150 gray (Gy) to the liver. Lung dose (D) will be calculated from the following formula: D=A*(1-S)*50/1. D=Planned dose absorbed by treated volume(Gy), A=Activity injected with microspheres (gigabequerel [GBq]), S=Percentage of pulmonary shunt, "1" assuming that the lung mass=1 kilograms [kg]). Number of treatments is up to Investigator's discretion while taking into account the cumulative dose to the liver and lung.
Receives: Device: TheraSphere

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS will be calculated as the interval between treatment administration and the date of death for any cause, opposition to data collection, or study termination, whichever occurs first.

    Measured: Treatment (Day 1) up to participant's death, opposition to data collection, or study termination (up to Year 6)

  2. QoL Measurements Using FACT-HEP Questionnaire Before and After Treatment

    Quality of Life (QoL) will be assessed by the Functional Assessment of Cancer Therapy (FACT-HEP) questionnaire prior to treatment on Day 1, every 2 to 4 months post treatment (follow up visits), and every standard of care (SOC) visit after Month 12 until the participant's death, opposition to data collection, study withdraw for any cause, or study termination. The FACT-Hep Questionnaire uses participant-reported outcome (PRO) scores. QoL scores of each domain at each time-point and their differences from baseline will be summarised. A deterioration in QoL is defined as a 7-point decline in the total score or death, whichever comes first. The time to deterioration in QoL will be calculated as the interval between first date of TheraSphere® treatment and deterioration in QoL. The higher the score, the better the QoL, with a range 0-180.

    Measured: Treatment (Day 1), every 2 to 4 months Post Treatment (maximum treatment time = up to Day 28), and SOC visits after Month 12 until up to participant's death, opposition to data collection, study withdraw for any cause, or study termination (up to Year 6)

Secondary outcomes (17)

  1. Number of Grade 3 or Higher Adverse Events (AEs) Related to Study treatment or Procedure

    An AE is any untoward medical occurrence or undesirable event experienced in a participant that begins or worsens following TheraSphere® administration. AEs will be classified using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0.

    Measured: Treatment (Day 1) up to 90 Days Post Treatment or the first post treatment follow-up visit after TheraSphere administration, if after 90 days (maximum treatment time = up to Day 28)

  2. Number of Participants Re-Hospitalised Following Treatment

    The number of participants re-hospitalised for any event related to TheraSphere® treatment during the study will be reported.

    Measured: Treatment (Day 1) up to Month 1 Post Treatment (maximum treatment time = up to Day 28)

  3. Duration of Re-Hospitalisations Following Treatment

    The duration of re-hospitalisations for any event related to TheraSphere® treatment during the study will be reported.

    Measured: Treatment (Day 1) up to Month 1 Post Treatment (maximum treatment time = up to Day 28)

  4. Number of Participants Achieving Treatment Expectation

    At Baseline and follow-up post treatment, participants' treatment expectation will be measured by a qualitative assessment according to Investigator's opinion, whether the goal is met or not. Before treatment the treatment goal will be documented. The number of participants achieving the treatment goal will be reported.

    Measured: Baseline up to Month 12 Post Treatment

  5. Number of Participants with Tumour Response

    Tumour Response will be based on the radiological tumour assessment and will be categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Tumour response will be assessed using Modified Response Evaluation Criteria in Solid Tumours (mRECIST) criteria or RECIST criteria

    Measured: Treatment (Day 1) up to Month 12 Post Treatment (maximum treatment time = up to Day 28)

  6. Number of Participants with an Alpha-Fetoprotein (AFP), CA 19-9, CEA tumour Response

    A Tumour response defined as a ≥50% decrease in: AFP levels for participants with a Baseline AFP level ≥200 nanograms/milliliter (ng/mL), CA 19-9 levels for participants with a baseline CA 19-9 level ≥ 2 x Upper Limit of Normal (ULN), CEA levels for participants with a baseline CEA level ≥ 2 x ULN.

    Measured: Treatment (Day 1) and Month 12 Post Treatment (maximum treatment time = up to Day 28)

  7. Number of Participants Receiving a Post TheraSphere Anti-Cancer Treatment

    The number of participants for which additional TheraSphere treatment or surgical procedure is required will be reported.

    Measured: Treatment (Day 1) up to participant's death, opposition to data collection, study withdraw for any cause, or study termination (up to Year 6)

  8. Number of Participants Reporting Best Supportive Care Treatment

    The number of participants for which additional anti-cancer treatment including additional TheraSphere treatment or surgical procedure will be reported.

    Measured: Treatment (Day 1) up to participant's death, opposition to data collection, study withdraw for any cause, or study termination (up to Year 6)

  9. Number of Participants per Type of Vascular Access Used to Administer TheraSphere

    The number of participants recorded for each type of vascular access (that is, Femoral/Radial-Humeral) will be reported.

    Measured: Treatment (Day1) upto Month 12

  10. Number of Participants with similar Tumour(s) Location at Baseline and the location of lesions targeted by 99mTc-MAA SPECT Imaging

    The Baseline computed tomography (CT)/magnetic resonance imaging (MRI) will be compared against 99mTc-MAA imaging (Single Proton Emission Computed Tomography [SPECT] or SPECT/CT) to evaluate the agreement in the lesion locations identified with 2 imaging methods. The 3 categories to report agreement between Baseline CT/MRI and 99mTc-MAA are: Optimal (images match), Sub optimal (less than 50% matching), and Non optimal (images do not match at all).

    Measured: Baseline and Post 99mTc-MAA Imaging (up to Day 28)

  11. Description of post treatment tumour targeting by determination of the number of patients with similar tumour(s) location at baseline and location of lesions targeted by Y-90 Positron Emission Tomography (PET)/CT or Y-90 PET/MRI or Y-90 SPECT/CT.

    The Baseline CT/MRI will be compared against the Post TheraSphere administration imaging (Y90-SPECT-CT, or Y90-PET-CT, or Y90-PET-MRI) to measure agreement in the lesion locations identified with the 2 imaging methods. The 3 categories to evaluate the agreement between Baseline CT/MRI and 99mTc-MAA are: Optimal (images match), Sub optimal (less than 50% matching), and Non optimal (images do not match at all).

    Measured: Baseline and Post TheraSphere Administration Imaging (up to Day 28)

  12. Description of pre and post treatment tumour targeting by determination of the number of patients with similar tumour(s) location based on 99mTc-MAA (SPECT or SPECT/CT and location of tumour targeted by Y-90 using post-treatment(PET/CT or PET/MRI or SPEC

    99mTc-MAA SPECT-CT will be compared against the Post TheraSphere administration (Y90-SPECT-CT, or Y90-PET-CT, or Y90-PET-MRI) to measure agreement in the lesion locations identified with the 2 imaging methods. The 3 categories to report agreement between Baseline 99mTc-MAA SPECT-CT and TheraSphere (Y90-SPECT-CT, or Y90-PET-CT, or Y90-PET-MRI) are: Optimal (images match), Sub optimal (less than 50% matching), and Non optimal (images do not match at all).

    Measured: Pre-Treatment Administration (Baseline) and Post-Treatment Administration (up to Day 28)

  13. Description of Portal Vein Thrombosis (PVT) targeting by determination of the number of patients with PVT at baseline that have the PVT targeted by 99mTc-MAA (SPECT or SPECT/CT), Y-90 (PET/CT or PET/MRI or SPECT/CT).

    Types of PVT will be classified according to the following scale: Vp0 Absent; Vp1 Presence or tumour thrombus distal to, but not in, the second-order branches of the portal vein; Vp2 Presence of tumour thrombus in first -order branches of the portal vein; Vp3 Presence of tumour thrombus in first-order branches of the portal vein; and Vp4 Presence of tumour thrombus in the main trunk of portal vein or a portal vein contralateral to the primary involved lobe (or both). In case of PVT (Vp1 to Vp4), the intensity of 99mTc-MAA and TheraSphere uptake on PVT (that is, greater activity than surrounding treated liver parenchyma) evaluated on 99mTc-MAA SPECT-CT, Y90-SPECT-CT, or Y90-PET-CT or Y90-PET-MRI imagings will be graded qualitatively as strong, weak or no uptake on PVT.

    Measured: Pre-Treatment Administration (Baseline) and Post-Treatment Administration (up to Day 28)

  14. Determination of a correlation between tumour and normal tissue liver absorbed doses, determined with 99mTc-MAA (SPECT or SPECT/CT), with qualitative tumour response (CR or PR), OS and safety, respectively as Assessed by Cox Regression Analyses

    A Cox regression analysis of OS will be performed to assess the impact of the tumour and normal liver tissue absorbed doses. This will be done separately for absorbed doses calculated before treatment administration with 99mTc-MAA (SPECT or SPECT/ CT) and estimated with post-treatment TheraSphere Y90-PET-CT or Y90-PET-MRI.

    Measured: Baseline and Post 99mTc-MAA Imaging (up to Day 28)

  15. Determination of a correlation between tumour and normal tissue liver absorbed doses, determined with Y-90 (PET/CT or PET/MRI), with qualitative tumour response (CR or PR), OS and safety, respectively.

    A logistic regression analysis of qualitative tumour/index lesion response (CR or PR) will be performed to assess the impact of the tumour/index lesion AD (i.e. the response variable is whether there was a response and the explanatory variable is the AD). This will be done separately for ADs from pre-procedural 99mTc-MAA (SPECT or SPECT/CT) and for post-procedural Y-90 PET/CT or PET/MRI. A Cox regression analyses of OS will be performed to assess the impact of the tumour ADs (i.e., the AD will be the explanatory variable). This will be done separately for AD by 99mTc-MAA (SPECT or SPECT/CT) and by post-treatment Y-90 PET/CT and/or PET/MRI. Logistic regression analyses of the occurrence of SAEs will be performed to assess the impact of the non-tumoural liver absorbed doses. This will be done separately for absorbed doses calculated before treatment administration with 99mTc-MAA (SPECT or SPECT/ CT) and estimated with post-treatment TheraSphere® Y90-PET-CT or Y90-PET-MRI

    Measured: Baseline and Post 99mTc-MAA Imaging (up to Day 28)

  16. Determination of a correlation between tumour and normal tissue liver absorbed doses determined with 99mTc-MAA (SPECT or SPECT/CT) and with Y-90 (PET/CT or PET/MRI)

    The relationship between absorbed doses derived from pre-procedural 99mTc-MAA (SPECT or SPECT/CT) imaging and post-treatment Y90 PET/CT or PET/MRI imaging will be assessed separately for normal tissue liver absorbed doses and tumour absorbed doses using Bland-Altman analysis.

    Measured: Baseline and Post 99mTc-MAA Imaging (up to Day 28)

  17. Determination of a correlation between Dose volume histogram (DVH) for total perfused tumour, Index lesion and whole normal liver tissue, using 99mTc-MAA (SPECT or SPECT/CT) and Y-90 (PET/CT or PET/MRI).

    The DVH using 99Tc-MAA and TheraSphere (Y90-SPECT-CT, Y90-PET-CT, or Y90-PET-MRI) will be reported for total perfused tumours, index lesions, and whole normal liver tissues. The observed counts will be presented. A linear regression of AD from pre-procedural 99mTc-MAA (SPECT or SPECT/CT) imaging and post-procedural Y-90 PET/CT or PET/MRI imaging will be performed and Pearson's correlation coefficient will be calculated.

    Measured: Baseline and Post 99mTc-MAA Imaging (up to Day 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start13 Mar 2019
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,247 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04069468
Sponsor's protocol ID
BTG-007996-01
Acronym
PROACTIF
Status last verified
Jun 2025
First submitted
22 Aug 2019
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guiu B, Bailly C, Vibert E, Tlili G, Mariano-Goulart D, Edeline J, Touchefeu Y, Durand E, Blanc JF, Chalaye J, Regnault H, Bouvier A, Sergent G, Sengel C, Renaud S, Rode A, Somma C, Chevallier P, Habouzit V, Brenot-Rossi I, Dohan A, Tselikas L, DeBaere T, Manfredi S, Dieudonne A, Fowers K, Boucher E, Patel B, Vicaut E, Garin E; PROACTIF Investigators Group. Effectiveness and safety of selective internal radiation therapy using yttrium-90 glass microspheres for hepatocellular carcinoma: real-world results from the multi-center prospective PROACTIF cohort of 989 patients. EClinicalMedicine. 2026 Apr 17;95:103884. doi: 10.1016/j.eclinm.2026.103884. eCollection 2026 May.

    PubMed 42023169

  • Garin E, Pinaquy JB, Bailly C, Sengel C, Mariano-Goulart D, Edeline J, Blanc JF, Bouvier A, Tordo J, Rode A, Becker S, Sefrioui D, de Baere T, Somma C, Mastier C, Goupil J, Chevallier P, Regnault H, Vibert E, Manfredi S, Vicaut E, Patel B, Boucher E, Guiu B; PROACTIF registry group. Evaluating the Effectiveness of Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Metastatic Colorectal Cancer in Practice: Protocol for the Prospective PROACTIF Phase IV Registry Study in France. Cardiovasc Intervent Radiol. 2022 Jan;45(1):1-11. doi: 10.1007/s00270-021-03002-0. Epub 2021 Nov 18.

    PubMed 34796373

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by Boston Scientific Corporation at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Treatment (Day 1) up to participant's death, opposition to data collection, or study termination (up to Year 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04069468, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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