Clinical trial · Observational
Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)
A Prospective, Post Approval, Multiple Centre, Open-Label, Non-Interventional, Registry Study to Evaluate Effectiveness of TheraSphere® in Clinical Practice in France
NCT04069468CI-TRIAL-00092534PROACTIFcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TheraSphere | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TheraSphere®
- description
- 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.
- interventionNames
- Device: TheraSphere
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- Treatment (Day 1) up to participant's death, opposition to data collection, or study termination (up to Year 6)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion: * Participant has received a reimbursed dose of TheraSphere® * Participant does not oppose to the collection of his/her medical personal data Exclusion: * Participant has opposed to data collection * Participant has not received a reimbursed dose of TheraSphere® (free of charge dose)
References
Publications (2)
- DERIVEDGuiu 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. PMID 42023169
- DERIVEDGarin 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. PMID 34796373