{"id":1895,"date":"2020-05-26T16:44:00","date_gmt":"2020-05-26T20:44:00","guid":{"rendered":"https:\/\/nanobiotix.com\/resource\/phase-i-ii-study-of-radiation-enhancing-hafnium-oxide-nanoparticles-nbtxr3-activated-by-sbrt-in-hcc-and-liver-metastases-patients\/"},"modified":"2024-10-29T08:50:19","modified_gmt":"2024-10-29T12:50:19","slug":"phase-i-ii-study-of-radiation-enhancing-hafnium-oxide-nanoparticles-nbtxr3-activated-by-sbrt-in-hcc-and-liver-metastases-patients","status":"publish","type":"resource","link":"https:\/\/nanobiotix.com\/fr\/resource\/phase-i-ii-study-of-radiation-enhancing-hafnium-oxide-nanoparticles-nbtxr3-activated-by-sbrt-in-hcc-and-liver-metastases-patients\/","title":{"rendered":"Phase I\/II Study Of Radiation Enhancing Hafnium Oxide Nanoparticles NBTXR3 Activated by SBRT in HCC and Liver Metastases Patients"},"content":{"rendered":"

[vc_row padding_top=”0″ padding_bottom=”0″ section_container_layout=”full-width” remove_horizontal_padding=”yes” module_type=”bg-color” gutter_size=”yes” equal_height=”yes” bg_color=”#28282e”][vc_column][vc_row_inner padding_top=”0″ padding_bottom=”0″ gutter_size=”yes” equal_height=”yes”][vc_column_inner column_paddings=”105″ column_position_vertical=”middle” column_min_height=”700″ column_min_height_sm=”400″ column_min_height_xs=”350″ module_type=”bg-image” bg_image=”99″ mask_fx=”yes-mask” mask_color_mode=”palette” mask_bg_color_palette=”main-mask” animation_fx=”yes-animation” animation_delay=”200″ animation_offset_scroll_down=”90″ width=”1\/2″ animation_in=”fadeInUp”][vc_empty_space height=”60px” responsive_lg=”hidden” responsive_md=”hidden”][az_box_icons box_icon_title=”Authors” box_icon_color_mode=”on-the-fly” icon_visibility=”yes-icon” icon_type=”font” icon=”fa fa-edit” icon_color_mode=”on-the-fly” icon_size=”50″ box_icon_color=”#ffffff” icon_color=”#ffffff”]De Baere T1<\/span>, Pracht M2<\/span>, Rolland Y3<\/span>, Durand-Labrunie J4<\/span>, Jaksic N5<\/span>, Nguyen TVF4<\/span>, J.P. Bronowicki6<\/span>, V. Vendrely7<\/span>, V. Crois\u00e9-Laurent6<\/span>, E. Rio8<\/span>, S. Le Sourd3<\/span>, P. Said9<\/span>, P. Gustin1<\/span>, C. Perret10<\/span>, D. Peiffert11<\/span>, E. Deutsch12<\/span>, E. Chajon Rodriguez13<\/span> 1 \u2014 Institut Gustave Roussy, Villejuif, France 2 \u2014 Centre Eug\u00e8ne Marquis, Rennes, France 3 \u2014 Centre Eug\u00e8ne Marquis, Rennes, France 4 \u2014 Gustave Roussy, Villejuif, France 5 \u2014 Centre Eug\u00e8ne-Marquis, Rennes, France 6 \u2014 Hopital de Brabois Adultes, Vandoeuvre-L\u00e8s-Nancy, France 7 \u2014 University Hospital of Bordeaux, Bordeaux, France 8 \u2014 Institut de Canc\u00e9rologie de l\u2019Ouest, Nantes, France 9 \u2014 Nanobiotix, Paris, France 10 \u2014 Institut de Canc\u00e9rologie de l\u2019Ouest, Nantes, France 11 \u2014 Institut de Canc\u00e9rologie de Lorraine, Vandoeuvre-Les-Nancy, France 12 \u2014 Gustave Roussy, Cancer Campus, Villejuif, France 13 \u2014 Centre Eug\u00e8ne Marquis \u2014 D\u00e9partement de Radioth\u00e9rapie, Rennes, France <\/span>[\/az_box_icons][vc_empty_space height=”60px” responsive_lg=”hidden” responsive_md=”hidden”][\/vc_column_inner][vc_column_inner column_paddings=”105″ column_position_vertical=”middle” module_type=”bg-color” animation_fx=”yes-animation” animation_delay=”300″ animation_offset_scroll_down=”90″ width=”1\/2″ bg_color=”#ffffff” animation_in=”fadeInUp”][vc_empty_space height=”60px” responsive_lg=”hidden” responsive_md=”hidden”][az_box_icons box_icon_title=”Summary” icon_visibility=”yes-icon” icon_type=”font” icon=”az-icon az-icon-layers2″ icon_color_mode=”on-the-fly” icon_color=”#28282e” icon_size=”50″]Purpose\/Objective(s):<\/b> Stereotactic body radiotherapy (SBRT) is a well-tolerated and valuable alternative for patients with unresectable hepatocellular carcinoma (HCC) or liver metastases (mets) who are not eligible for standard treatment such as surgery, local ablation or chemoembolization. Yet, the energy dose delivered to the tumor is limited due to potential toxicity to healthy tissues and the need to preserve liver function. Thus, achieving local control in liver cancers remains a challenge. The first-in-class radioenhancer NBTXR3 (hafnium oxide nanoparticles), administered by intratumoral (IT) injection once prior to RT treatment, augments the energy dose deposit within tumor cells when activated by RT. The result is increased tumor cell death compared to RT alone without increasing radiation exposure to surrounding tissues. Patients with HCC or mets may benefit from this new approach. Here we report on a phase I\/II study evaluating NBTXR3 activated by SBRT in these patients. Materials\/Methods:<\/b> In the phase I part of the study [NCT02721056], five NBTXR3 dose levels equivalent to 10, 15, 22, 33, and 42% of baseline tumor volume are tested following a traditional 3+3 design. NBTXR3 is administered by IT injection followed by SBRT (45 Gy \/ 3 fractions \/ 5-7 days or 50 Gy \/ 5 fractions \/ 15 days). Primary endpoints include determination of the recommended phase 2 dose (RP2D) based on the incidence of the early DLTs. Secondary endpoints include the safety profile, liver disease scores evolution, and early efficacy by target lesions response rate (mRECIST\/RECIST 1.1). Results:<\/b> To date, 22 patients have been treated and the 4 first dose levels are completed with 6 patients at 10% (2 SBRT doses tested due to organ constraints), 4 patients each at 15% and 22% (due to fiducial displacement and incomplete injected dose) and 3 patients at 33%. The last dose level (42%) is ongoing with 5 patients treated so far. No early DLT has been observed at any dose level. Five AEs (3 G1-2; 2 G3) related to the injection and 4 AEs related to NBTXR3 (3 G1-2; 1 G3), including 1 SAE (bile duct stenosis, also related to RT) were observed. No grade 4-5 AEs were observed. CT-scan showed no leakage of NBTXR3 into surrounding healthy tissues and SBRT safety profile was as expected. No clinically meaningful changes in CPS and APRI were observed post-treatment. In patients evaluable for efficacy, best observed target lesion responses were 5 complete response and 3 partial response in HCC patients (n = 8) and, 5 partial response and 1 stable disease in liver mets patients (n = 6). Conclusion:<\/b> NBTXR3 intratumoral injection is feasible and NBTXR3 demonstrates a very good safety and tolerability profile thus far. Recruitment is nearly completed at the 42% dose level. Early efficacy results highlight the potential for NBTXR3 to improve the clinical outcomes of patients with unresectable primary or metastatic liver cancer.[\/az_box_icons][vc_empty_space height=”60px” responsive_lg=”hidden” responsive_md=”hidden”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"wds_primary_resource_type":0,"wds_primary_data_type":0,"wds_primary_indication":0,"wds_primary_platform_type":0,"footnotes":""},"resource_type":[31],"data_type":[25],"indication":[32],"platform_type":[36],"class_list":["post-1895","resource","type-resource","status-publish","hentry","resource_type-abstracts","data_type-clinical","indication-liver","platform_type-nbtxr3"],"acf":[],"_links":{"self":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource\/1895","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource"}],"about":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/types\/resource"}],"version-history":[{"count":0,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource\/1895\/revisions"}],"wp:attachment":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=1895"}],"wp:term":[{"taxonomy":"resource_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource_type?post=1895"},{"taxonomy":"data_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/data_type?post=1895"},{"taxonomy":"indication","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/indication?post=1895"},{"taxonomy":"platform_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/platform_type?post=1895"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}