{"id":112410,"date":"2024-01-02T19:36:00","date_gmt":"2024-01-02T11:36:00","guid":{"rendered":"https:\/\/gothe.tw\/?p=112410"},"modified":"2024-01-02T19:36:00","modified_gmt":"2024-01-02T11:36:00","slug":"%e5%9c%8b%e9%bc%8e%e7%94%9f%e6%8a%80%e6%8e%a5%e7%8d%b2cro%e6%a9%9f%e6%a7%8b%e9%80%9a%e7%9f%a5%e5%ae%8c%e6%88%90%e8%bd%89%e7%a7%bb%e6%80%a7%e8%83%b0%e8%87%9f%e7%99%8c%e4%ba%ba%e9%ab%94i-ii%e6%9c%9f","status":"publish","type":"post","link":"https:\/\/gothe.tw\/?p=112410","title":{"rendered":"\u570b\u9f0e\u751f\u6280\u63a5\u7372CRO\u6a5f\u69cb\u901a\u77e5\u5b8c\u6210\u8f49\u79fb\u6027\u80f0\u81df\u764c\u4eba\u9ad4I\/II\u671f\u81e8\u5e8a\u8a66\u9a57\u7d71\u8a08\u6578\u64da"},"content":{"rendered":"
\n
\n

\u53f0\u5317<\/span>2024\u5e741\u67082\u65e5<\/span> \/\u7f8e\u901a\u793e\/ \u2014 \u570b\u9f0e\u751f\u7269\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\u65bc\u53f0\u7063\u6642\u95932024\/01\/02\u63a5\u7372CRO\u6a5f\u69cb\u901a\u77e5\u5b8c\u6210\u8f49\u79fb\u6027\u80f0\u81df\u764c\u4eba\u9ad4I\/II\u671f\u81e8\u5e8a\u8a66\u9a57\u7d71\u8a08\u6578\u64da\uff0c\u4e3b\u8981\u6578\u64da<\/span>(Full Analysis Set)\u5982\u4e0b<\/span>:
\u00a0 (1)\u4e2d\u4f4d\u6578\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f<\/span>(Median PFS): 5.3\u500b\u6708<\/span>(\u4e3b\u8981\u8a55\u4f30\u6307\u6a19<\/span>)
\u00a0 (2)6\u500b\u6708\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u7387<\/span>(PFS rate): 41.7%(\u4e3b\u8981\u8a55\u4f30\u6307\u6a19<\/span>)
\u00a0 (3)\u4e2d\u4f4d\u6578\u6574\u9ad4\u5b58\u6d3b\u671f<\/span>(Median OS): 14.1\u500b\u6708<\/span>(\u6b21\u8981\u8a55\u4f30\u6307\u6a19<\/span>)
\u00a0 (4)6\u500b\u6708\u5b58\u6d3b\u7387<\/span>(OS rate): 85.5%(\u6b21\u8981\u8a55\u4f30\u6307\u6a19<\/span>)
\u00a0 (5)12\u500b\u6708\u5b58\u6d3b\u7387<\/span>(OS rate): 62.2%(\u6b21\u8981\u8a55\u4f30\u6307\u6a19<\/span>)<\/p>\n

\u672c\u8a66\u9a57\u70ba\u7814\u767c\u4e2d\u53e3\u670d\u5291\u578b\u65b0\u85e5Antroquinonol(Hocena)\u806f\u5408\u80f0\u81df\u764c\u6a19\u6e96\u6cbb\u7642\u6cd5\uff0c\u91dd\u5c0d\u8f49\u79fb\u6027\u80f0\u81df\u764c\u7684\u7b2c\u4e00\u7dda\u7528\u85e5\u3002\u672c\u8a66\u9a57\u70ba\u55ae\u81c2\u7814\u7a76\uff0c\u8207\u6a19\u6e96\u6cbb\u7642(nab-paclitaxel + gemcitabine combination)\u7684III\u671f\u7814\u7a76\u7d50\u679c\u76f8\u6bd4\uff0cAntroquinonol\u806f\u5408\u6a19\u6e96\u6cbb\u7642\u5f8c\uff0c\u4e2d\u4f4d\u6578\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f(Median PFS)\u70ba5.3\u500b\u6708\uff0c\u4f4e\u65bc\u6a19\u6e96\u6cbb\u7642\u6cd5\u70ba5.5\u500b\u6708\uff1b6\u500b\u6708\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u7387(PFS rate)\u70ba41.7%\uff0c\u4f4e\u65bc\u6a19\u6e96\u6cbb\u7642\u6cd5\u70ba44%\uff1b\u4e2d\u4f4d\u6578\u6574\u9ad4\u5b58\u6d3b\u671f(median OS)\u70ba14.1\u500b\u6708\uff0c\u9ad8\u65bc\u6a19\u6e96\u6cbb\u7642\u6cd5\u70ba8.5\u500b\u6708\uff1b6\u500b\u6708\u6574\u9ad4\u5b58\u6d3b\u7387\u70ba85.5%\uff0c\u9ad8\u65bc\u6a19\u6e96\u6cbb\u7642\u6cd5\u70ba67%\uff1b12\u500b\u6708\u6574\u9ad4\u5b58\u6d3b\u7387\u70ba62.2%\uff0c\u9ad8\u65bc\u6a19\u6e96\u6cbb\u7642\u6cd5\u70ba35%\u3002<\/p>\n

\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40(FDA)\u5b9a\u7fa9\u5728\u7279\u5b9a\u75be\u75c5\u7684\u80cc\u666f\u4e0b\u5177\u6709\u81e8\u5e8a\u610f\u7fa9(clinically meaningful)\u7684\u7a4d\u6975\u6cbb\u7642\u6548\u679c\u88ab\u7a31\u70ba\u300c\u81e8\u5e8a\u76ca\u8655\u300d(clinical benefit)\u3002\u53e6\u7f8e\u570b\u81e8\u5e8a\u816b\u7624\u91ab\u5b78\u6703(ASCO)\u7684\u5c08\u5bb6\u59d4\u54e1\u6703\u70ba\u80f0\u81df\u764c\u3001\u4e73\u764c\u3001\u80ba\u764c\u53ca\u5927\u8178\u764c\u81e8\u5e8a\u8a66\u9a57\u5b9a\u7fa9\u4e86\u5177\u6709\u81e8\u5e8a\u610f\u7fa9\u7684\u76ee\u6a19\uff0c\u5176\u4e2d\u91dd\u5c0d\u80f0\u81df\u764c\u7b26\u5408gemcitabine\u6216(Nab-paclitaxel + gemcitabine)\u8cc7\u683c\u7684\u60a3\u8005\uff0c\u4e2d\u4f4d\u6578\u7e3d\u5b58\u6d3b\u671f(mOS)\u7d04\u70ba8\u81f39\u500b\u6708\uff0c\u82e5\u8207\u7576\u524d\u7684\u6a19\u6e96\u7642\u6cd5\u4e4b\u7e3d\u5b58\u6d3b\u671f\u76f8\u6bd4\uff0c\u6539\u55843\u81f34\u500b\u6708\u4ee5\u4e0a\u5247\u88ab\u8a8d\u70ba\u5177\u6709\u81e8\u5e8a\u610f\u7fa9\u7684\u7d50\u679c(clinically meaningful outcomes)\u3002<\/p>\n

\u672c\u6b21\u7d71\u8a08\u6578\u64da\u89c0\u5bdf\u5230\u5728\u4e2d\u4f4d\u6578\u6574\u9ad4\u5b58\u6d3b\u671f\u30016\u500b\u6708\u5b58\u6d3b\u7387\u53ca12\u500b\u6708\u5b58\u6d3b\u7387\u8868\u73fe\u8f03\u4f73\uff0c\u570b\u9f0e\u751f\u6280\u5c07\u91dd\u5c0d\u6b64\u7d71\u8a08\u7d50\u679c\u8207\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40(FDA)\u53ca\u6b50\u6d32\u85e5\u54c1\u5c40(EMA)\u8a0e\u8ad6\u7533\u8acb\u5b64\u5152\u85e5\u85e5\u8b49\u8a08\u756b\u3002<\/p>\n

Antroquinonol\u5408\u4f75\u7642\u6cd5\u8207\u6a19\u6e96\u6cbb\u7642(nab-paclitaxel + gemcitabine) \u53cagemcitabine\u55ae\u7368\u6cbb\u7642\uff0c\u9019\u4e09\u7d44\u6cbb\u7642\u65b9\u6cd5\u6bd4\u8f03\u6578\u64da\u5982\u4e0b:
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (a)\u4e2d\u4f4d\u6578\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u5206\u5225\u70ba5.3\u30015.5\u53ca3.7\u500b\u6708\u3002
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (b)6\u500b\u6708\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u7387\u5206\u5225\u70ba41.7%\u300144%\u53ca25%
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (c)\u6574\u9ad4\u5b58\u6d3b\u671f\u5206\u5225\u70ba14.1\u30018.5\u53ca6.7\u500b\u6708\u3002
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (d)6\u500b\u6708\u7684\u6574\u9ad4\u5b58\u6d3b\u7387\u5206\u5225\u70ba85.5%\u300167%\u53ca55%
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (e)12\u500b\u6708\u7684\u6574\u9ad4\u5b58\u6d3b\u7387\u5206\u5225\u70ba62.2%\u300135%\u53ca22%\u3002<\/p>\n

Antroquinonol\u806f\u5408\u6a19\u6e96\u6cbb\u7642\u8207\u53e6\u4e00\u7a2e\u6cbb\u7642\u8f49\u79fb\u6027\u80f0\u817a\u764c\u7684\u85e5\u7269FOLFIRINOX\u3002
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u9019\u4e8c\u7d44\u6cbb\u7642\u65b9\u6cd5\u6bd4\u8f03\u6578\u64da\u5982\u4e0b\uff1a
\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0(a)\u4e2d\u4f4d\u6578\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u671f\u5206\u5225\u70ba5.3\u53ca6.4\u500b\u6708\u3002
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (b)6\u500b\u6708\u75be\u75c5\u7121\u60e1\u5316\u5b58\u6d3b\u7387\u5206\u5225\u70ba41.7%\u53ca53%
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (c)\u6574\u9ad4\u5b58\u6d3b\u671f\u5206\u5225\u70ba14.1\u53ca11.1\u500b\u6708\u3002
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (d)6\u500b\u6708\u7684\u6574\u9ad4\u5b58\u6d3b\u7387\u5206\u5225\u70ba85.5%\u53ca76%
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 (e)12\u500b\u6708\u7684\u6574\u9ad4\u5b58\u6d3b\u7387\u5206\u5225\u70ba62.2%\u53ca48%\u3002<\/p>\n

\u6b64\u5916\uff0c\u6a19\u6e96\u6cbb\u7642(nab-paclitaxel + gemcitabine combination)\u6240\u5f15\u8d77\u7684\u8840\u6db2\u76f8\u95dc\u4e0d\u826f\u4e8b\u4ef6\uff0c\u5305\u62ec\u4e2d\u6027\u7c92\u7d30\u80de\u6e1b\u5c11\u75c7\u3001\u8840\u5c0f\u677f\u6e1b\u5c11\u75c7\u53ca\u8ca7\u8840\uff0c\u6240\u6709\u7b49\u7d1a\u7684\u4e0d\u826f\u53cd\u61c9\u767c\u751f\u7387\u5728\u672c\u6b21\u8a66\u9a57\u4e2d\u5747\u5f97\u5230\u986f\u8457\u6539\u5584\u3002\u5728\u975e\u8840\u6db2\u65b9\u9762\u7684\u75b2\u52de\u3001\u812b\u9aee\u3001\u5468\u570d\u795e\u7d93\u75c5\u8b8a\u53ca\u812b\u6c34\u7b49\u4e0d\u826f\u53cd\u61c9\u4e4b\u767c\u751f\u7387\u4e5f\u964d\u4f4e\uff0c\u5728\u5641\u5fc3\u3001\u5614\u5410\u53ca\u8179\u7009\u7b49\u4e0d\u826f\u53cd\u61c9\u767c\u751f\u7387\u5247\u986f\u8457\u589e\u52a0\uff0c\u4f46\u5728\u8178\u80c3\u9053\u6700\u5e38\u898b\u4e4b\u4e0d\u826f\u53cd\u61c9\u7686\u70ba\u8f15\u5ea6\u81f3\u4e2d\u5ea6\u3002\u672c\u7814\u7a76\u7d50\u679c\u8868\u660e\uff0cAntroquinonol\u806f\u5408\u6a19\u6e96\u6cbb\u7642(nab-paclitaxel + gemcitabine)\u7684\u5b89\u5168\u6027\u662f\u53ef\u4ee5\u7ba1\u63a7\u7684\u3002<\/p>\n

\u672c\u8a66\u9a57\u7684Antroquinonol\u806f\u5408\u7642\u6cd5\u70ba\u8f49\u79fb\u6027\u80f0\u817a\u764c\u60a3\u8005\u63d0\u4f9b\u4e86\u4e00\u7a2e\u6f5b\u5728\u7684\u4e00\u7dda\u6cbb\u7642\u9078\u64c7\uff0c\u6b64\u8a66\u9a57\u7d50\u679c\u652f\u6301\u66f4\u64f4\u5927\u898f\u6a21\u3001\u96a8\u6a5f\u53ca\u5c0d\u7167\u7814\u7a76\u4ee5\u8b49\u5be6\u672c\u7814\u7a76\u7d50\u679c\u3002<\/p>\n<\/div>\n

\n\u65b0\u805e\u4f86\u6e90\uff1aPR Newswire<\/p>\n

\u4ee5\u4e0a\u65b0\u805e\u6295\u7a3f\u5167\u5bb9\u7531PR Newswire \u7f8e\u901a\u793e\u5168\u6b0a\u81ea\u8ca0\u8cac\u4efb\uff0c\u82e5\u6709\u6d89\u53ca\u4efb\u4f55\u9055\u53cd\u6cd5\u4ee4\u3001\u9055\u53cd\u672c\u7db2\u7ad9\u6703\u54e1\u689d\u6b3e\u3001\u6709\u4fb5\u5bb3\u7b2c\u4e09\u4eba\u6b0a\u76ca\u4e4b\u865e\uff0c\u5c07\u4e00\u6982\u7531PR Newswire \u7f8e\u901a\u793e\u627f\u64d4\u6cd5\u5f8b\u53ca\u640d\u5bb3\u8ce0\u511f\u4e4b\u8cac\u4efb\uff0c\u8207\u65b0\u982d\u689dThehubnews\u7121\u95dc\u3002<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u53f0\u53172024\u5e741\u67082\u65e5 \/\u7f8e\u901a\u793e\/ \u2014 \u570b\u9f0e<\/p>\n","protected":false},"author":6,"featured_media":112411,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[423],"class_list":["post-112410","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life","tag-423","two-columns"],"_links":{"self":[{"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/posts\/112410","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=112410"}],"version-history":[{"count":0,"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/posts\/112410\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/media\/112411"}],"wp:attachment":[{"href":"https:\/\/gothe.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=112410"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=112410"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=112410"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}