{"id":3107,"date":"2022-06-06T08:55:51","date_gmt":"2022-06-06T07:55:51","guid":{"rendered":"https:\/\/bibliography.nanobiotix.com\/?p=3107"},"modified":"2022-06-06T08:56:15","modified_gmt":"2022-06-06T07:56:15","slug":"2020-esmo-nbtxr3-in-hcc-and-liver-metastases","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2020-esmo-nbtxr3-in-hcc-and-liver-metastases\/","title":{"rendered":"2020 \u2013 ESMO \u2013 NBTXR3 in HCC and Liver Metastases"},"content":{"rendered":"

[vc_row padding_top=\u00a0\u00bb0″ padding_bottom=\u00a0\u00bb0″ section_container_layout=\u00a0\u00bbfull-width\u00a0\u00bb remove_horizontal_padding=\u00a0\u00bbyes\u00a0\u00bb module_type=\u00a0\u00bbbg-color\u00a0\u00bb gutter_size=\u00a0\u00bbyes\u00a0\u00bb equal_height=\u00a0\u00bbyes\u00a0\u00bb bg_color=\u00a0\u00bb#28282e\u00a0\u00bb][vc_column][vc_row_inner padding_top=\u00a0\u00bb0″ padding_bottom=\u00a0\u00bb0″ gutter_size=\u00a0\u00bbyes\u00a0\u00bb equal_height=\u00a0\u00bbyes\u00a0\u00bb][vc_column_inner column_paddings=\u00a0\u00bb105″ column_position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb column_min_height=\u00a0\u00bb700″ column_min_height_sm=\u00a0\u00bb400″ column_min_height_xs=\u00a0\u00bb350″ module_type=\u00a0\u00bbbg-image\u00a0\u00bb bg_image=\u00a0\u00bb102″ mask_fx=\u00a0\u00bbyes-mask\u00a0\u00bb mask_color_mode=\u00a0\u00bbpalette\u00a0\u00bb mask_bg_color_palette=\u00a0\u00bbmain-mask\u00a0\u00bb animation_fx=\u00a0\u00bbyes-animation\u00a0\u00bb animation_delay=\u00a0\u00bb200″ animation_offset_scroll_down=\u00a0\u00bb90″ width=\u00a0\u00bb1\/2″ animation_in=\u00a0\u00bbfadeInUp\u00a0\u00bb][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][az_box_icons box_icon_title=\u00a0\u00bbAuthors\u00a0\u00bb box_icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_visibility=\u00a0\u00bbyes-icon\u00a0\u00bb icon_type=\u00a0\u00bbfont\u00a0\u00bb icon=\u00a0\u00bbfa fa-edit\u00a0\u00bb icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_size=\u00a0\u00bb50″ box_icon_color=\u00a0\u00bb#ffffff\u00a0\u00bb icon_color=\u00a0\u00bb#ffffff\u00a0\u00bb]Thierry de Ba\u00e8re1<\/span>, Marc Pracht2<\/span>, Yann Rolland2<\/span>, J\u00e9r\u00f4me Durand-Labrunie1<\/span>, Nicolas Jaksic2<\/span>, France Nguyen1<\/span>, Jean-Pierre Bronowicki3<\/span>, V\u00e9ronique Vendrely4<\/span>, Val\u00e9rie Crois\u00e9-Laurent3<\/span>, Emmanuel Rio5<\/span>, Samuel Le Sourd2<\/span>, Patricia Said6<\/span>, Pierre Gustin1<\/span>, Christophe Perret5<\/span>, Didier Peiffert7<\/span>, Eric Deutsch1<\/span>, Enrique Chajon2<\/span>
\n
\n1 \u2013 Institut Gustave Roussy, Villejuif, France
\n2 \u2013 Centre Eugene – Marquis, Rennes, France
\n3 \u2013 CHRU de Nancy \u2013 H\u00f4pital de Brabois, Vandoeuvre-l\u00e8s-Nancy, France
\n4 \u2013 CHU de Bordeaux \u2013 H\u00f4pital Haut-L\u00e9v\u00eaque, Pessac, France
\n5 \u2013 Institut de canc\u00e9rologie de l’Ouest, Nantes, France
\n6 \u2013 Nanobiotix, SA, Paris, France
\n7 \u2013 Radiotherapy, Institut de Canc\u00e9rologie de Lorraine, Nancy, France
\n<\/span>[\/az_box_icons][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][\/vc_column_inner][vc_column_inner column_paddings=\u00a0\u00bb105″ column_position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb module_type=\u00a0\u00bbbg-color\u00a0\u00bb animation_fx=\u00a0\u00bbyes-animation\u00a0\u00bb animation_delay=\u00a0\u00bb300″ animation_offset_scroll_down=\u00a0\u00bb90″ width=\u00a0\u00bb1\/2″ bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb animation_in=\u00a0\u00bbfadeInUp\u00a0\u00bb][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][az_box_icons box_icon_title=\u00a0\u00bbSummary\u00a0\u00bb icon_visibility=\u00a0\u00bbyes-icon\u00a0\u00bb icon_type=\u00a0\u00bbfont\u00a0\u00bb icon=\u00a0\u00bbaz-icon az-icon-layers2″ icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_color=\u00a0\u00bb#28282e\u00a0\u00bb icon_size=\u00a0\u00bb50″]Background:<\/strong> NBTXR3, functionalized hafnium oxide nanoparticles, administered by intratumoral injection (ITI) and activated by radiotherapy (RT), such as stereotactic body RT (SBRT), increases energy deposit inside tumor cells and subsequently tumor cell death compared to RT alone, while sparing healthy tissues. This innovative approach, which does not engage liver and renal functions, might benefit patients (pts) with unresectable liver cancers.<\/p>\n

Methods:<\/strong> Phase I\/II clinical trial to evaluate NBTXR3 administered by ITI activated by SBRT(45 Gy \/ 3 fractions \/ 5-7 days or 50 Gy \/ 5 fractions \/ up to 15 days) in pts with hepatocellular carcinoma (HCC) or liver metastases [NCT02721056]. Phase I 3+3 dose escalation scheme with 5 NBTXR3 dose levels: 10, 15, 22, 33, and 42% of baseline tumor volume. Primary endpoints include Recommended Phase 2 Dose (RP2D) determination and early DLT incidence. Secondary endpoints include safety profile, liver disease scores evolution, and early efficacy by response rate (mRECIST\/RECIST 1.1).<\/p>\n

Results:<\/strong> Enrolment at all dose levels is complete, 23 pts treated: 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), 3 pts at 33% and 6 pts at 42%. No early DLT was observed at any dose level. 1 SAE (late onset G3 bile duct stenosis) related to NBTXR3 and RT occurred at 22%. No clinically meaningful changes in Child-Pugh score and APRI were observed post-treatment. There were 11 AEs related to NBTXR3 and\/or ITI, of which grade 3 AEs were: 2 abdominal pain (ITI related) and 1 bile duct stenosis (NBTXR3 related) No grade 4-5 AEs were observed.
\nCT-scan showed NBTXR3 within tumor without leakage to healthy tissues. To date, the best observed responses assessed by MRI in target lesions from evaluable pts for HCC (n=11) were 5 CR, 5 PR, 1 SD and for metastases (n=7) 5 PR, 2 SD.<\/p>\n

Conclusions:<\/strong> NBTXR3 has demonstrated a very good safety and tolerability profile in these patient populations. The RP2D has been determined to be 42% of tumor volume. Early efficacy results highlight the potential for NBTXR3 to address an unmet medical need in pts with unresectable primary or metastatic liver cancer. [\/az_box_icons][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"

NBTXR3, functionalized hafnium oxide nanoparticles, administered by intratumoral injection (ITI) and activated by radiotherapy (RT), such as stereotactic body RT (SBRT), increases energy deposit inside tumor cells and subsequently tumor cell death compared to RT alone, while sparing healthy tissues. This innovative approach, which does not engage liver and renal functions, might benefit patients (pts) with unresectable liver cancers. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":2228,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183,669],"tags":[196,572,620,545,342,565,200,483,573],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/3107"}],"collection":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/comments?post=3107"}],"version-history":[{"count":1,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/3107\/revisions"}],"predecessor-version":[{"id":3109,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/3107\/revisions\/3109"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/2228"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=3107"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=3107"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=3107"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}