{"id":38197,"date":"2026-02-02T16:18:56","date_gmt":"2026-02-02T08:18:56","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=38197"},"modified":"2026-02-02T16:18:37","modified_gmt":"2026-02-02T08:18:37","slug":"fda%e5%bf%ab%e9%80%9f%e9%80%9a%e9%81%93%e8%b5%84%e6%a0%bc%e6%8e%88%e4%ba%88%e6%96%b0%e5%9e%8b%e5%85%8d%e7%96%ab%e8%81%94%e5%90%88%e6%96%b9%e6%a1%88%ef%bc%8c%e7%94%a8%e4%ba%8emss%e8%bd%ac%e7%a7%bb","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/fda%e5%bf%ab%e9%80%9f%e9%80%9a%e9%81%93%e8%b5%84%e6%a0%bc%e6%8e%88%e4%ba%88%e6%96%b0%e5%9e%8b%e5%85%8d%e7%96%ab%e8%81%94%e5%90%88%e6%96%b9%e6%a1%88%ef%bc%8c%e7%94%a8%e4%ba%8emss%e8%bd%ac%e7%a7%bb\/","title":{"rendered":"FDA\u5feb\u901f\u901a\u9053\u8d44\u683c\u6388\u4e88\u65b0\u578b\u514d\u75ab\u8054\u5408\u65b9\u6848\uff0c\u7528\u4e8eMSS\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c"},"content":{"rendered":"\n

1. \u6838\u5fc3\u8981\u70b9\u901f\u89c8<\/strong><\/strong><\/p>\n\n\n\n

\u2022 \u4e00\u79cd\u65b0\u578b\u6297CTLA-4\u5355\u6297\u4e0ePD-1\u6291\u5236\u5242\u7684\u8054\u5408\u65b9\u6848\uff0c\u56e0II\u671f\u4e34\u5e8a\u7814\u7a76\u663e\u793a\u51fa\u79ef\u6781\u7597\u6548\u4e0e\u826f\u597d\u5b89\u5168\u6027\uff0c\u88ab\u7f8e\u56fd\u76d1\u7ba1\u673a\u6784\u6388\u4e88\u201c\u5feb\u901f\u901a\u9053\u8d44\u683c\u201d\u3002<\/p>\n\n\n\n

\u2022 \u8be5\u6297CTLA-4\u5355\u6297\u91c7\u7528\u201c\u80bf\u7624\u5fae\u73af\u5883\u9009\u62e9\u6027\u6fc0\u6d3b\u201d\u7684\u63a9\u853d\u8bbe\u8ba1\uff0c\u6709\u671b\u5728\u63d0\u9ad8\u7ed9\u836f\u5242\u91cf\u7684\u540c\u65f6\u964d\u4f4e\u7cfb\u7edf\u6027\u6bd2\u6027\u3002<\/p>\n\n\n\n

\u2022 \u8be5\u7b56\u7565\u4e3a\u4f20\u7edf\u514d\u75ab\u6cbb\u7597\u53cd\u5e94\u4e0d\u4f73\u7684\u5fae\u536b\u661f\u7a33\u5b9a\u578b\uff08MSS\uff09\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u63d0\u4f9b\u4e86\u65b0\u7684\u6f5c\u5728\u6cbb\u7597\u65b9\u5411\u3002<\/p>\n\n\n\n

2. \u5feb\u901f\u901a\u9053\u8d44\u683c\u6388\u4e88\u80cc\u666f<\/strong><\/strong><\/p>\n\n\n\n

FDA\u8fd1\u65e5\u6388\u4e88muzastotug\uff08ADG126\uff09\u8054\u5408pembrolizumab\u7528\u4e8e\u6cbb\u7597\u65e0\u6d3b\u52a8\u6027\u809d\u8f6c\u79fb\u7684MSS\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\uff08mCRC\uff09\u6210\u4eba\u60a3\u8005\u4ee5\u5feb\u901f\u901a\u9053\u8d44\u683c\u3002<\/p>\n\n\n\n

\u8be5\u51b3\u5b9a\u57fa\u4e8e\u4e00\u9879\u6b63\u5728\u8fdb\u884c\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6240\u79ef\u7d2f\u7684\u7597\u6548\u4e0e\u5b89\u5168\u6027\u6570\u636e\uff0c\u76f8\u5173\u66f4\u65b0\u7ed3\u679c\u5df2\u57282025\u5e74ASCO\u5e74\u4f1a\u4e0a\u516c\u5e03\u3002\u5feb\u901f\u901a\u9053\u8d44\u683c\u7684\u6388\u4e88\uff0c\u65e8\u5728\u52a0\u901f\u5177\u6709\u6f5c\u5728\u4e34\u5e8a\u4ef7\u503c\u3001\u53ef\u6ee1\u8db3\u91cd\u5927\u672a\u6ee1\u8db3\u533b\u7597\u9700\u6c42\u7684\u521b\u65b0\u7597\u6cd5\u7684\u7814\u53d1\u4e0e\u5ba1\u8bc4\u8fdb\u7a0b\u3002<\/p>\n\n\n\n

\u4e0e\u5fae\u536b\u661f\u9ad8\u5ea6\u4e0d\u7a33\u5b9a\u578b\uff08MSI-H\uff09\u7ed3\u76f4\u80a0\u764c\u4e0d\u540c\uff0cMSS mCRC\u5bf9\u4f20\u7edf\u514d\u75ab\u68c0\u67e5\u70b9\u6291\u5236\u5242\u666e\u904d\u53cd\u5e94\u6709\u9650\uff0c\u957f\u671f\u4ee5\u6765\u7f3a\u4e4f\u6709\u6548\u7684\u514d\u75ab\u6cbb\u7597\u65b9\u6848\u3002<\/p>\n\n\n\n

Muzastotug\u662f\u4e00\u79cd\u63a9\u853d\u578b\u6297CTLA-4IgG1\u5355\u514b\u9686\u6297\u4f53\uff0c\u5176\u5173\u952e\u8bbe\u8ba1\u7279\u70b9\u5728\u4e8e\uff1a<\/strong><\/strong><\/p>\n\n\n\n

\u2022 \u901a\u8fc7\u53ef\u5207\u5272\u7684\u63a9\u853d\u80bd\u6bb5\uff0c\u4f7f\u6297\u4f53\u4e3b\u8981\u5728\u80bf\u7624\u5fae\u73af\u5883\u4e2d\u88ab\u6fc0\u6d3b\u3002<\/p>\n\n\n\n

\u2022 \u7ed3\u5408\u7279\u5b9a\u8868\u4f4d\u963b\u65adCTLA-4\u529f\u80fd\uff0c\u589e\u5f3aT\u7ec6\u80de\u542f\u52a8\u3002<\/p>\n\n\n\n

\u2022 \u540c\u65f6\u901a\u8fc7\u589e\u5f3a\u6297\u4f53\u4f9d\u8d56\u7684\u7ec6\u80de\u6bd2\u4f5c\u7528\u6216\u541e\u566c\u4f5c\u7528\uff0c\u964d\u4f4e\u80bf\u7624\u514d\u75ab\u6291\u5236\u6027\u8c03\u8282\u6027T\u7ec6\u80de\u6c34\u5e73\u3002<\/p>\n\n\n\n

\u8fd9\u4e00\u8bbe\u8ba1\u4f7f\u5176\u5728\u4e0ePD-1\u6291\u5236\u5242\u8054\u5408\u4f7f\u7528\u65f6\u53ef\u8010\u53d7\u66f4\u9ad8\u5242\u91cf\uff0c\u5728\u7406\u8bba\u4e0a\u517c\u987e\u7597\u6548\u63d0\u5347\u4e0e\u7cfb\u7edf\u6027\u514d\u75ab\u6bd2\u6027\u964d\u4f4e\uff0c\u4e3aMSS\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u63d0\u4f9b\u4e86\u65b0\u7684\u514d\u75ab\u8c03\u63a7\u8def\u5f84\u3002<\/p>\n\n\n\n

3. \u5f53\u524d\u4e34\u5e8a\u7814\u53d1\u8fdb\u5c55<\/strong><\/strong><\/p>\n\n\n\n

\u76ee\u524d\u7684\u968f\u673aII\u671f\u7814\u7a76\u8bbe\u8ba1\u5982\u4e0b\uff1a<\/strong><\/strong><\/p>\n\n\n\n

\u60a3\u8005\u968f\u673a\u63a5\u53d710mg\/kg\u621620mg\/kg\u5242\u91cf\u7684muzastotug\uff0c\u8054\u5408pembrolizumab\uff1b\u91c7\u7528\u8bf1\u5bfc-\u7ef4\u6301\u7ed9\u836f\u7b56\u7565\uff1b\u4e0d\u8bbe\u7f6e\u5355\u836f\u5bf9\u7167\u7ec4\uff0c\u6bcf\u4e2a\u5242\u91cf\u7ec4\u8ba1\u5212\u5165\u7ec4\u7ea630\u4f8b\u60a3\u8005\u3002<\/p>\n\n\n\n

\u5165\u7ec4\u6807\u51c6\u5305\u62ec\uff1a<\/strong><\/strong><\/p>\n\n\n\n

\u5e74\u9f84\u226518\u5c81\u7684MSS mCRC\u60a3\u8005\uff1bECOG\u4f53\u80fd\u72b6\u6001\u8bc4\u52060\u20131\u5206\uff1b\u81f3\u5c11\u5b58\u57281\u4e2a\u53ef\u6d4b\u91cf\u75c5\u7076\uff08RECIST1.1\uff09\uff1b\u5668\u5b98\u529f\u80fd\u826f\u597d\uff0c\u5e76\u5728\u5165\u7ec4\u524d2\u5e74\u5185\u6709\u80bf\u7624\u7ec4\u7ec7\u6837\u672c\u3002\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u6db5\u76d6\u6700\u5927\u8010\u53d7\u5242\u91cf\u3001\u63a8\u8350II\u671f\u5242\u91cf\u3001\u5b89\u5168\u6027\u3001\u8010\u53d7\u6027\u53ca\u521d\u6b65\u6297\u80bf\u7624\u6d3b\u6027\u8bc4\u4f30\u3002<\/p>\n\n\n\n

4. \u7597\u6548\u4e0e\u5b89\u5168\u6027\u6570\u636e<\/strong><\/strong><\/p>\n\n\n\n

\u5728ASCO\u5e74\u4f1a\u4e0a\u516c\u5e03\u7684\u6570\u636e\u663e\u793a\uff1a10mg\/kg\u5242\u91cf\u7ec4\uff08n=29\uff09\uff1b\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\uff1a17%\uff1b\u75be\u75c5\u63a7\u5236\u7387\uff08DCR\uff09\uff1a76%\uff1b6\u4e2a\u6708\u4e34\u5e8a\u83b7\u76ca\u7387\uff1a38%\uff1b\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\uff1a4.8\u4e2a\u6708\uff1b\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\uff1a6.2\u4e2a\u6708\uff1b20mg\/kg\u5242\u91cf\u7ec4\uff08n=21\uff09\uff0cORR\uff1a29%\uff0cDCR\uff1a81%\uff1b\u4e2d\u4f4dPFS\u5c1a\u672a\u8fbe\u5230\uff1b6\u4e2a\u6708PFS\u7387\u7ea650%\uff1b\u5728\u4e2d\u4f4d\u968f\u8bbf17.8\u4e2a\u6708\u65f6\uff0c\u6574\u4f53\u4e2d\u4f4d\u603b\u751f\u5b58\u671f\uff08OS\uff09\u8fbe\u523019.4\u4e2a\u6708\u3002<\/p>\n\n\n\n

5. \u5b89\u5168\u6027\u6982\u51b5<\/strong><\/strong><\/p>\n\n\n\n

\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u5728\u4e24\u4e2a\u5242\u91cf\u7ec4\u4e2d\u5747\u8f83\u4e3a\u5e38\u89c1\uff0c\u4f46\u6574\u4f53\u53ef\u63a7\uff1a<\/strong>\u5e38\u89c1\u4e0d\u826f\u53cd\u5e94\u5305\u62ec\u7619\u75d2\u3001\u8179\u6cfb\u3001\u7532\u72b6\u817a\u529f\u80fd\u51cf\u9000\u3001\u4e4f\u529b\u53ca\u80be\u4e0a\u817a\u529f\u80fd\u4e0d\u5168\uff1b\u672a\u89c2\u5bdf\u5230\u5242\u91cf\u9650\u5236\u6027\u6bd2\u6027\uff1b\u672a\u51fa\u73b04\u7ea7\u62165\u7ea7\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff1b\u56e0\u4e0d\u826f\u53cd\u5e94\u5bfc\u81f4\u7684\u6cbb\u7597\u4e2d\u65ad\u7387\u4ec5\u7ea64%\u3002<\/p>\n\n\n\n

6. \u4e0b\u4e00\u6b65\u8ba1\u5212<\/strong><\/strong><\/p>\n\n\n\n

\u57fa\u4e8e\u5f53\u524d\u7814\u7a76\u7ed3\u679c\u53ca\u76d1\u7ba1\u673a\u6784\u53cd\u9988\uff0c\u6ce8\u518c\u6027III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u9884\u8ba1\u4e8e2027\u5e74\u542f\u52a8\uff0c\u4e3b\u8981\u7ec8\u70b9\u4e3a\u603b\u751f\u5b58\u671f\uff08OS\uff09\uff1b\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u3001\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u53ca\u5ba2\u89c2\u7f13\u89e3\u7387\uff1b\u5bf9\u7167\u7ec4\u5c06\u91c7\u7528\u5f53\u524d\u6807\u51c6\u6cbb\u7597\u65b9\u6848\u3002<\/p>\n\n\n\n

\u5728\u514d\u75ab\u6cbb\u7597\u957f\u671f\u201c\u96be\u4ee5\u653b\u514b\u201d\u7684MSS\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u9886\u57df\uff0c\u57fa\u4e8e\u63a9\u853d\u6297CTLA-4\u6297\u4f53\u7684\u8054\u5408\u514d\u75ab\u7b56\u7565\u6b63\u9010\u6b65\u663e\u73b0\u51fa\u4e34\u5e8a\u6f5c\u529b\u3002<\/p>\n\n\n\n

\u8f6c\u8f7d\u8bf7\u8054\u7cfb\u6388\u6743\uff0c\u6216\u6ce8\u660e\u6765\u6e90\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

1. \u6838\u5fc3\u8981\u70b9\u901f\u89c8 \u2022 \u4e00\u79cd\u65b0\u578b\u6297CTLA-4\u5355\u6297\u4e0ePD-1\u6291\u5236\u5242\u7684\u8054\u5408\u65b9\u6848\uff0c\u56e0II\u671f\u4e34\u5e8a\u7814\u7a76\u663e\u793a\u51fa<\/p>\n","protected":false},"author":14,"featured_media":38180,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1769,1741],"tags":[],"yst_prominent_words":[],"class_list":["post-38197","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-treatment-zh-hans","category-colorectal-cancer-zh-hans"],"_links":{"self":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/38197","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\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/comments?post=38197"}],"version-history":[{"count":4,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/38197\/revisions"}],"predecessor-version":[{"id":38228,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/posts\/38197\/revisions\/38228"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/media\/38180"}],"wp:attachment":[{"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/media?parent=38197"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/categories?post=38197"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/tags?post=38197"},{"taxonomy":"yst_prominent_words","embeddable":true,"href":"https:\/\/www.hkioc.com.hk\/zh-hans\/wp-json\/wp\/v2\/yst_prominent_words?post=38197"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}