{"id":1890,"date":"2020-12-20T14:54:00","date_gmt":"2020-12-20T19:54:00","guid":{"rendered":"https:\/\/nanobiotix.com\/resource\/estro-nbtxr3-for-the-treatment-of-advanced-liver-cancers\/"},"modified":"2024-10-29T08:50:17","modified_gmt":"2024-10-29T12:50:17","slug":"estro-nbtxr3-for-the-treatment-of-advanced-liver-cancers","status":"publish","type":"resource","link":"https:\/\/nanobiotix.com\/fr\/resource\/estro-nbtxr3-for-the-treatment-of-advanced-liver-cancers\/","title":{"rendered":"ESTRO &#8211; NBTXR3 for the Treatment of Advanced Liver Cancers"},"content":{"rendered":"<p>[vc_row padding_top=&#8221;0&#8243; padding_bottom=&#8221;0&#8243; section_container_layout=&#8221;full-width&#8221; remove_horizontal_padding=&#8221;yes&#8221; module_type=&#8221;bg-color&#8221; gutter_size=&#8221;yes&#8221; equal_height=&#8221;yes&#8221; bg_color=&#8221;#28282e&#8221;][vc_column][vc_row_inner padding_top=&#8221;0&#8243; padding_bottom=&#8221;0&#8243; gutter_size=&#8221;yes&#8221; equal_height=&#8221;yes&#8221;][vc_column_inner column_paddings=&#8221;105&#8243; column_position_vertical=&#8221;middle&#8221; column_min_height=&#8221;700&#8243; column_min_height_sm=&#8221;400&#8243; column_min_height_xs=&#8221;350&#8243; module_type=&#8221;bg-image&#8221; bg_image=&#8221;102&#8243; mask_fx=&#8221;yes-mask&#8221; mask_color_mode=&#8221;palette&#8221; mask_bg_color_palette=&#8221;main-mask&#8221; animation_fx=&#8221;yes-animation&#8221; animation_delay=&#8221;200&#8243; animation_offset_scroll_down=&#8221;90&#8243; width=&#8221;1\/2&#8243; animation_in=&#8221;fadeInUp&#8221;][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][az_box_icons box_icon_title=&#8221;Authors&#8221; box_icon_color_mode=&#8221;on-the-fly&#8221; icon_visibility=&#8221;yes-icon&#8221; icon_type=&#8221;font&#8221; icon=&#8221;fa fa-edit&#8221; icon_color_mode=&#8221;on-the-fly&#8221; icon_size=&#8221;50&#8243; box_icon_color=&#8221;#ffffff&#8221; icon_color=&#8221;#ffffff&#8221;]Thierry de Ba\u00e8re<span class=\"notes up\">1<\/span>, Marc Pracht<span class=\"notes up\">2<\/span>, Yann Rolland<span class=\"notes up\">2<\/span>, J\u00e9r\u00f4me Durand-Labrunie<span class=\"notes up\">1<\/span>, France Nguyen<span class=\"notes up\">1<\/span>, Jean-Pierre Bronowicki<span class=\"notes up\">3<\/span>, V\u00e9ronique Vendrely<span class=\"notes up\">4<\/span>, Antonio Sa Cunha<span class=\"notes up\">5<\/span>, Val\u00e9rie Crois\u00e9-Laurent<span class=\"notes up\">3<\/span>, Emanuel Rio<span class=\"notes up\">6<\/span>, Samuel Le Sourd<span class=\"notes up\">2<\/span>, Patricia Said<span class=\"notes up\">8<\/span>, Pierre Gustin<span class=\"notes up\">1<\/span>, Christophe Perret<span class=\"notes up\">6<\/span>, Didier Peiffert<span class=\"notes up\">7<\/span>, Eric Deutsch<span class=\"notes up\">1<\/span>, Enrique Chajon<span class=\"notes up\">2<\/span> <span class=\"notes\"> 1 &#8211; Institut Gustave Roussy, Villejuif, FR 2 &#8211; Centre Eugene &#8211; Marquis, Rennes, FR 3 &#8211; CHRU de Nancy &#8211; H\u00f4pital de Brabois, Vandoeuvre-l\u00e8s-Nancy, FR 4 &#8211; CHU de Bordeaux &#8211; H\u00f4pital Haut-L\u00e9v\u00eaque, Pessac, FR 5 &#8211; Centre H\u00e9pato-Biliaire Paul Brousse, Villejuif, FR 6 &#8211; Institut de canc\u00e9rologie de l&#8217;Ouest, Nantes, FR 7 &#8211; Radiotherapy, Institut de Canc\u00e9rologie de Lorraine, Nancy, FR 8 &#8211; Nanobiotix, SA, Paris, FR <\/span>[\/az_box_icons][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][\/vc_column_inner][vc_column_inner column_paddings=&#8221;105&#8243; column_position_vertical=&#8221;middle&#8221; module_type=&#8221;bg-color&#8221; animation_fx=&#8221;yes-animation&#8221; animation_delay=&#8221;300&#8243; animation_offset_scroll_down=&#8221;90&#8243; width=&#8221;1\/2&#8243; bg_color=&#8221;#ffffff&#8221; animation_in=&#8221;fadeInUp&#8221;][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][az_box_icons box_icon_title=&#8221;Summary&#8221; icon_visibility=&#8221;yes-icon&#8221; icon_type=&#8221;font&#8221; icon=&#8221;az-icon az-icon-layers2&#8243; icon_color_mode=&#8221;on-the-fly&#8221; icon_color=&#8221;#28282e&#8221; icon_size=&#8221;50&#8243;]<strong>Purpose\/Objective:<\/strong> The use of stereotactic body radiotherapy (SBRT) for the local control of unresectable hepatocellular carcinoma (HCC) or liver metastases (mets) is well tolerated but limited by the need to preserve liver function. Increasing energy deposit within the tumor without increasing toxicity in healthy tissues remains a major challenge in radiation oncology. NBTXR3 (hafnium oxide nanoparticles), a first-in-class radioenhancer when activated by RT augments energy dose deposit within tumor cells, increasing tumor cell death compared to RT alone, while sparing healthy tissues.\u00a0Patients (pts) with HCC or mets may benefit from the mode of action of NBTXR3. A phase I\/II clinical trial has been conducted to evaluate NBTXR3 activated by SBRT in these pts [NCT02721056].  <strong>Material\/Methods:<\/strong> The Phase I is a 3+3 dose escalation scheme with 5 NBTXR3 dose levels: 10, 15, 22, 33, and 42% of baseline tumor volume. NBTXR3 has been administered by intratumoral injection (ITI) followed by SBRT (45 Gy \/ 3 fractions \/ 5 to 7 days or 50 Gy \/ 5 fractions \/ 15 days). Primary endpoints were determination of the RP2D and early DLTs. Secondary endpoints included the safety profile, liver disease scores evolution, and early efficacy by response rate (mRECIST\/RECIST 1.1).  <strong>Results:<\/strong> Twenty pts have been treated. The dose levels of 10, 15, 22 and 33% are completed: 6 pts at 10% (2 SBRT doses tested due to organ constraints), 4 pts each at 15% and 22% (due to fiducial displacement and ITI shift) and 3 pts at 33%. The final (42%) dose escalation level is ongoing with 3 pts treated thus far. No early DLT has been observed. One SAE (G3 bile duct stenosis) related to NBTXR3 and RT occurred at the 22% dose level. Adverse events related to ITI or NBTXR3 were: G2 malaise at the 10% dose level, 2 G3 abdominal pain at 15%, G1 pleural effusion and G3 bile duct stenosis at 22% and G1 fatigue at 33%. No clinically meaningful changes in CPS and APRI were observed post-treatment and CT-scan showed no leakage of NBTXR3 into surrounding healthy tissues. Best observed response in evaluable patients for HCC (n=8) were 5 CR, 3 PR and for mets (n=5) the results were: 4 PR, 1 SD.  <strong>Conclusion:<\/strong> Intratumoral injection of NBTXR3 is feasible, demonstrated a very good safety and tolerability profile up to the 42% dose level. Recruitment at the 42% dose level is nearly finalized. Early efficacy results suggest NBTXR3 has the potential to address an unmet medical need in pts with unresectable primary or metastatic liver cancer.[\/az_box_icons][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][\/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-1890","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\/1890","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\/1890\/revisions"}],"wp:attachment":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=1890"}],"wp:term":[{"taxonomy":"resource_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource_type?post=1890"},{"taxonomy":"data_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/data_type?post=1890"},{"taxonomy":"indication","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/indication?post=1890"},{"taxonomy":"platform_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/platform_type?post=1890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}