Last updated on February 2018

NBTXR3 Crystalline Nanoparticles and Stereotactic Body Radiation Therapy in the Treatment of Liver Cancers

Brief description of study

The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.

Detailed Study Description

This is a prospective, open-label, non-comparative and non-randomized study, to be conducted in 2 phases:

  • a dose-escalation phase, to determine the recommended dose of NBTXR3 and to evaluate its safety/tolerability and preliminary clinical activity; and
  • a dose-expansion phase, which will be a cohort expansion at the recommended dose of NBTXR3.

Patients will receive a single administration of NBTXR3 on day of injection, as a super selective transcatheter arterial or intrahepatic lesion injection activated by Stereotactic Body Radiation Therapy starting 24 hours post injection. The total radiotherapy dose will be maximum 45 Gy, delivered as three fractions of 15 Gy each max, over 5 to 7 days (45 Gy, 3x15 Gy, over 5 to 7 days).

the visit of End of Treatment (EOT) will take place 12 to 13 weeks after the administration of the last radiotherapy fraction and includes the evaluation of global clinical, radiological and laboratory parameters.

Clinical Study Identifier: NCT02721056

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Philippe Merle, MD-PhD

CHU La Croix Rousse
Lyon, France
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BAUMANN Anne Sophie, MD

Institut de Canc rologie de Loraine
Nancy, France
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Nancy, France
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RIO Emmanuel, MD

Centre Ren Gauducheau
Nantes, France
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VENDRELY Veronique, MD

H pital Haut-L v que
Pessac, France
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Centre Eug ne Marquis
Rennes, France
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Institut Gustave Roussy
Villejuif, France
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