{"id":20658,"date":"2024-11-04T10:30:53","date_gmt":"2024-11-04T02:30:53","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=20658"},"modified":"2025-05-26T23:10:16","modified_gmt":"2025-05-26T15:10:16","slug":"fda-%e6%89%b9%e5%87%86-zolbetuximab-%e8%81%94%e5%90%88%e5%8c%96%e7%96%97%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97-cldn18-2-%e9%98%b3%e6%80%a7%e7%9a%84%e8%83%83%e7%99%8c%e6%88%96%e8%83%83%e9%a3%9f%e7%ae%a1","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/fda-%e6%89%b9%e5%87%86-zolbetuximab-%e8%81%94%e5%90%88%e5%8c%96%e7%96%97%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97-cldn18-2-%e9%98%b3%e6%80%a7%e7%9a%84%e8%83%83%e7%99%8c%e6%88%96%e8%83%83%e9%a3%9f%e7%ae%a1\/","title":{"rendered":"FDA \u6279\u51c6 zolbetuximab \u8054\u5408\u5316\u7597\u7528\u4e8e\u6cbb\u7597 CLDN18.2 \u9633\u6027\u7684\u80c3\u764c\u6216\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\u817a\u764c"},"content":{"rendered":"\n

2024\u5e7410\u670818\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6\u4e86zolbetuximab-clzb\u8054\u5408\u542b\u6c1f\u5627\u5576\u548c\u542b\u94c2\u5316\u7597\uff0c\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597\u6210\u4eba\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u7684HER2\u9634\u6027\u7684\u80c3\u6216\u80c3\u98df\u7ba1\u4ea4\u754c\u5904(GEJ)\u817a\u764c\uff0c\u5176\u80bf\u7624\u7ecfFDA\u6279\u51c6\u7684\u8bd5\u9a8c\u786e\u5b9a\u4e3aCLDN18.2\u9633\u6027\u3002\u5176\u5efa\u8bae\u5242\u91cf\u4e3a\u7b2c\u4e00\u5242 800 mg\/m2\uff0c\u7136\u540e\u6bcf 3 \u5468\u4e00\u6b21 600 mg\/m2\uff0c\u540e\u7eed\u5242\u91cf\u6bcf 2 \u5468\u4e00\u6b21 400 mg\/m2\u3002<\/p>\n\n\n\n

\u8be5\u836f\u83b7\u5f97\u6279\u51c6\u4e3b\u8981\u662f\u6839\u636e3\u671fSPOTLIGHT (NCT03504397)\u548cGLOW(NCTO3653507)\u8bd5\u9a8c\u6570\u636e\u7684\u652f\u6301\u3002<\/p>\n\n\n\n

SPOTLIGHT\u7814\u7a76\u7ed3\u679c<\/strong><\/strong><\/p>\n\n\n\n

\u8fd9\u9879\u5168\u7403\u6027\u3001\u968f\u673a\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u53cc\u76f2SPOTLIGHT\u8bd5\u9a8c\u62db\u52df\u4e86\u6210\u5e74\u7684\u3001cldn18.2\u9633\u6027\u3001\u63a5\u53d7\u542b\u94c2\u4e00\u7ebf\u5316\u7597\u7684\u3001her2\u9634\u6027\u3001\u65e2\u5f80\u672a\u6cbb\u7597\u3001\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216HER\u9634\u6027\u3001\u8f6c\u79fb\u6027\u80c3\u6216GEJ\u817a\u764c\u7684\u60a3\u8005\u3002<\/p>\n\n\n\n

\u63a5\u53d7zolbetuximab + mFOLFOX6\u6cbb\u7597\u7684\u60a3\u8005(n = 283)\u7684\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f(PFS)\u4e3a10.6\u4e2a\u6708\uff0c\u800c\u63a5\u53d7\u5b89\u6170\u5242\/\u5316\u7597\u7ec4\u7684\u60a3\u8005(n = 282)\u4e3a8.7\u4e2a\u6708\uff0czolbetuximab\u7ec4\u7684\u4e2d\u4f4d\u603b\u751f\u5b58\u671f(OS)\u4e3a18.2\u4e2a\u6708\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u7684\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\u4e3a15.5\u4e2a\u6708\u3002<\/p>\n\n\n\n

\u6700\u5e38\u89c1\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff08AE\uff09\u5305\u62ec\u5455\u5410\u3001\u6076\u5fc3\u3001\u55dc\u4e2d\u6027\u767d\u8840\u7403\u51cf\u5c11\u75c7\u3001\u55dc\u4e2d\u6027\u767d\u8840\u7403\u51cf\u5c11\u75c7\u3001\u8179\u6cfb\u3001\u80a0\u6897\u963b\u3001\u53d1\u70ed\u3001\u80ba\u708e\u3001\u547c\u5438\u8870\u7aed\u3001\u80ba\u6813\u585e\u3001\u98df\u6b32\u4e0b\u964d\u548c\u8d25\u8840\u75c7\u3002<\/p>\n\n\n\n

GLOW\u7814\u7a76\u7ed3\u679c<\/strong><\/strong><\/p>\n\n\n\n

\u5728\u5168\u7403\u968f\u673a\u53cc\u76f2GLOW\u8bd5\u9a8c\u4e2d\uff0c\u7814\u7a76\u4eba\u5458\u62db\u52df\u4e86CLDN18.2\u9633\u6027\u3001HER2\u9634\u6027\u3001\u5148\u524d\u672a\u6cbb\u7597\u3001\u5c40\u90e8\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u80c3\/GEJ\u80bf\u7624\u7684\u6210\u5e74\u60a3\u8005\u3002<\/p>\n\n\n\n

507\u540d\u60a3\u8005\u88ab\u968f\u673a\u5206\u4e3a\u63a5\u53d7zolbetuximab-clzb\u8054\u5408CAPOX\u5316\u7597\u6216\u5b89\u6170\u5242\u8054\u5408CAPOX\u5316\u7597\u3002zolbetuximab-clzb\/\u5316\u7597\u7ec4\u7684\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u4e3a8.2\u4e2a\u6708\uff0c\u5b89\u6170\u5242\/\u5316\u7597\u7ec4\u4e3a6.8\u4e2a\u6708\u3002\u800cOS\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\u5206\u522b\u4e3a14.4\u4e2a\u6708\u548c12.2\u4e2a\u6708\u3002<\/p>\n\n\n\n

\u81f3\u5c11 2% \u7684\u60a3\u8005\u6700\u5e38\u89c1\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u5305\u62ec\u5455\u5410\u3001\u6076\u5fc3\u3001\u98df\u6b32\u4e0b\u964d\u3001\u8840\u5c0f\u677f\u8ba1\u6570\u4e0b\u964d\u3001\u4e0a\u6d88\u5316\u9053\u51fa\u8840\u3001\u8179\u6cfb\u3001\u80ba\u708e\u3001\u80ba\u6813\u585e\u548c\u53d1\u70ed\u3002<\/p>\n\n\n\n

\u5bf9\u4e8e\u957f\u671f\u4ee5\u6765\u53d7\u80c3\u764c\u6216\u80c3\u98df\u7ba1\u4ea4\u754c\u5904\u817a\u764c\u56f0\u6270\u7684\u60a3\u8005\u4eec\uff0c\u8fd9\u4e00\u6279\u51c6\u65e0\u7591\u662f\u4e00\u9053\u66d9\u5149\u3002\u5b83\u4e0d\u4ec5\u4e3a\u60a3\u8005\u63d0\u4f9b\u4e86\u65b0\u7684\u6cbb\u7597\u9014\u5f84\uff0c\u4e5f\u4e3a\u533b\u751f\u4eec\u5728\u6cbb\u7597\u51b3\u7b56\u4e0a\u63d0\u4f9b\u4e86\u6709\u529b\u7684\u652f\u6301\u3002\u968f\u7740\u8fd9\u4e00\u7597\u6cd5\u7684\u5e94\u7528\uff0c\u66f4\u591a\u7684\u60a3\u8005\u6709\u671b\u83b7\u5f97\u66f4\u597d\u7684\u6cbb\u7597\u6548\u679c\uff0c\u5ef6\u957f\u751f\u547d\uff0c\u63d0\u9ad8\u751f\u6d3b\u8d28\u91cf\u3002<\/p>\n\n\n\n

\u8f6c\u8f7d\u8bf7\u8054\u7cfb\u6388\u6743\uff0c\u6216\u6ce8\u660e\u6765\u6e90<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

2024\u5e7410\u670818\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6\u4e86zolbetuximab-clzb\u8054\u5408\u542b\u6c1f\u5627\u5576\u548c\u542b<\/p>\n","protected":false},"author":4,"featured_media":20734,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1756],"tags":[],"yst_prominent_words":[],"class_list":["post-20658","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-stomach-cancer-zh-hans"],"_links":{"self":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/20658","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/comments?post=20658"}],"version-history":[{"count":2,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/20658\/revisions"}],"predecessor-version":[{"id":20751,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/20658\/revisions\/20751"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/media\/20734"}],"wp:attachment":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/media?parent=20658"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/categories?post=20658"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/tags?post=20658"},{"taxonomy":"yst_prominent_words","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/yst_prominent_words?post=20658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}