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·|û¡GKO10139074 µoªí®É¶¡:2017/9/13 ¤W¤È 07:02:30²Ä 572 ½g¦^À³
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·|û¡G¦×©@10141509 µoªí®É¶¡:2017/9/12 ¤U¤È 11:23:30²Ä 571 ½g¦^À³
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ÁÂÁ¦Ѵ¤j¤j¨¯W¬Ý§¹¶E«áÁÙ¼·ªÅ¨Ó¬°§Ú̸Ѵb ³o§¾ªÑ³Q¥´¤@ÂI¤]¤£Þ Ä~Äò¨c¨c©ê¦í¥_·¥¬P |
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·|û¡G¦Ñ´10141055 µoªí®É¶¡:2017/9/12 ¤U¤È 11:07:23²Ä 570 ½g¦^À³
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¦×©@¤j,¤Ñ©R¤j---¦³ªÅ¨Ó°Ñ¥[¥_·¥¬Pªºªk»¡·|¡A¦Ñ´n¥´§Ą⪺¤p§¾§¾¡I¦]¬°Åý¦Ñ´¬Ý¤F¤@½gÄê¤å³¹¡I Hepko-V5¬O¤°»ò°ªF¦è¡H»X¥j¤j¤Òªº»X¥j¥P¤¦¡H¡I¥i±¤¡A¦pªG¬O¦b¥xÆW¡A¥²´IÀ³¸Ó´N¥i¥H¦A¶}¤@ª©¤¦¹©¡I ¦³FDAªºorphan drug©Mµn¿ýclinical trial¤£¤@©w´N¬O«~½è«OÃÒ§r~~ Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L J Hepatocell Carcinoma. 2017; 4: 59¡V69. ClinicalTrials.gov registry site with ID: NCT02256514. ¬O³o¤@½g¨S¿ù§a¡H¦Ñ´§i¶D§AÌ´Xӫܲ³æªº¦a¤è¿ë¯u°°¡I 1.µoªí¦bJ Hepatocell Carcinoma¡A³o¬O¤°»ò°´Á¥Z¡H·d¤£¦n°³£¤£¬Ý¡I³o¼Ë»¡¤@ÂI³£¤£¬°¹L¡A¦]¬° ³o¬O¤@½g¥Ñ§ë½Z§@ªÌ¥I¶O(US$1,980)ªº§K¶O´Á¥Z¡A¨S¦³SCI impact factor(¬ì¾Ç¤Þ¥Î¼vÅT«Y¼Æ)¡C ¡´¦³¨S¦³·Q¹L¬°¤°»ò³o»ò¦nªº¼Æ¾ÚNEJM,Nature,Lancet,Cancer,JCO³o¨Ç³»¦y´Á¥Z³£¤£¦¬¿ý¡H³Ì«á§ë¤F§Ö¨â¦~ ¨S¤Hn¡A¥u¦n¦Û¤v¥I¿ú§ë¨ì¤@®a©M¶BÄF¶°¹Î®t¤£¦hªº´Á¥Z¤½¥q¡H 2.Mongolia¬O¤°»ò°¦a¤è¡H ¡´¥@¬ÉÂå¾Ç½×¤å»R¹ú«e¤T¦W¡÷¦L«×¡B¤¤°ê¡B¥ì®Ô¡I¨S¦³»X¥j¤£¥Nªí¥L¤£»R¹ú¡A¬O¦]¬°¥Lªº¶q¤Ö¨ì³s»R¹ú ªº¶q³£¤£¨¬¡IÀ´¤F¶Ü¡H 3.±qDec 2010 ~ Nov 2015, 75Ó HCC¯f¤H¡Aretrospective(¦^·¹)¥h¬Ý´¿¸g¥ÎÃĪº®ÄªG¡I³o¤@ÂI´N¬O ÄY«P©R¶Ë¡A©Ò¥H¦n¤@ÂIªº´Á¥Z³£§ë¤£¤W¡I¬°¤°»ò¡H n¥ý·dÀ´¤°»ò¬Oretrospective(¦^·¹)¤°»ò¬Oprospective(«e¤) -retrospective(¦^·¹)´N¬OÂå®v¥ÎÃĪº®ÉԨ䣪¾¹D³o¨Ç¯f¤H¬On°µÁ{§É¬ã¨sªº¡A¬O5¦~«áªº¬Y¤@¤Ñ¬ðµM ¤ß¦å¨Ó¼é¡A·Q¤ÀªR¬Ý¬Ý³o5¦~¨Ó±µ¨ü¬YºØªvÀøªº¯f¤Hªº¼Æ¾Ú¦p¦ó¡H¯ÊÂI¬O¼Æ¾Ú¤@©w´Ý¯Ê¤£¥þ¡I -prospective(«e¤)´N¬OÂå®v¥ÎÃĤ§«e´Nª¾¹D³o¨Ç¯f¤H¬On¯Ç¤JÁ{§É¬ã¨sªº¡Astudy designªº¯Ç¤J±ø¥ó¡B ±Æ°£±ø¥ó¡Bn°lÂܪº«ü¼Ð(AFP,ORR,mOS,mPFS....etc)¤~·|¨Æ¥ý´N§¹³Æ¦n¡I ©Ò¥H -¦pªG³o¤@½g¦p§@ªÌ»¡ªº¬Oretrospective(¦^·¹)¡A¥L̤£¥i¯à³o»òª¯«Ë¹B¡A©Ò¦³¯f¤Hªº¨C¤@Ó«ü¼Ð(¦pAFP,CT scan)³£Åç¨ì¤F¡I -¤]¦³¥i¯à¨ä¹ê°µ¤F7500Ó¯f¤H¡A¥u¬D¦³ÀËÅç¨ì¬ÛÃö¼Æ¾Úªº¡B®ÄªG¤ñ¸û¦nªº75Ó¯f¤Hªº¼Æ¾Ú¨Ó§e²{¡I -¼Æ¾Ú¬O½Ö§PŪªº¡H¤]³\±qÀY¨ì§À³£¬O®º³yªº¡I -³o»ò§¹¾ãªº¼Æ¾Ú¡AÀ³¸Ó¬Oprospective(«e¤)¡A«oµw³Q§@ªÌ»¡¬Oretrospective(¦^·¹)¡A¨º´N¬O¥Nªí¨S¦³Åý ¯f¤H¨Æ¥ýª¾±¡¡AÄY«¹H¤ÏÁ{§É¬ã¨sÛ²z¡A«ç»ò¥i¯à¦p§@ªÌ©Ò»¡²Å¦Xdeclaration of Helsinki¡H¦p¬O¡A§@ªÌªÖ©w¨S°áÀ´ Helsinkiªº³W½d¡I ¦A¬Ý¥L̵n¿ýªºphase 3 ClinicalTrials.gov Identifier:NCT02232490 Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC) Actual Study Start Date: January 2015 Estimated Study Completion Date: December 2018 ¡´4¦~¥´ºâ¦¬120Ó¯f¤H¡A³o¼Ë·Q®³ÃÄÃÒ¡H¦b¨º¸Ì¥i¥H¥æ©ö³o®a¤½¥qªºªÑ²¼¡H¦Ñ´Ä@ªÅ¦º¥L¡I Primary Outcome Measures: •changes in plasma AFP [ Time Frame: 3 months ] Changes in plasma AFP levels at monthly intervals ¡´phase 3ªº¥Dn«ü¼Ð¬ÝAFP¡A³o¼Ë·Q®³ÃÄÃÒ¡H¦b¨º¸Ì¥i¥H¥æ©ö³o®a¤½¥qªºªÑ²¼¡H¦Ñ´Ä@ªÅ¦º¥L¡I Secondary Outcome Measures: •CT scan [ Time Frame: 3 months ] changes in tumor size/mumber at 3 months compared to baseline ¡´phase 3ªº¦¸n«ü¼Ð¬ÝORR¡A³o¼Ë·Q®³ÃÄÃÒ¡H¦b¨º¸Ì¥i¥H¥æ©ö³o®a¤½¥qªºªÑ²¼¡H¦Ñ´Ä@ªÅ¦º¥L¡I Other Outcome Measures: •adverse effects [ Time Frame: 3 months ] evaluation of adverse effects if any ¡´phase 3ªº¨ä¥L«ü¼Ð¬Ý°Æ§@¥Î¡A³o¼Ë·Q®³ÃÄÃÒ¡H¦b¨º¸Ì¥i¥H¥æ©ö³o®a¤½¥qªºªÑ²¼¡H¦Ñ´Ä@ªÅ¦º¥L¡I ü~°ê®aªº±Æ¦W¦³®ÉÔÁÙ¯uªº®¼«nªº¡I¥xÆW¥Í§Þn¥[ªo¡A¤£¯à¦A²V¤F¡I ccc¤j¡An¶K¤å¤~µo²{§Aªº¤å³¹¡A½Ð¬Ý ·|û¡G¦Ñ´10141055 µoªí®É¶¡:2017/9/6 ¤U¤È 10:59:04²Ä 476 ½g¦^À³ ¦Ñ´¤w¸gµ¥³o½g¾ã¾ã6¤Ñ¤F¡AÁ`ºâµoªí¡A½Ñ§g½Ð¬Ý¡IÀu¦H¥ß§P¡I¤£n§i¶D¦Ñ´§A¤£ª¾¹DNature¬O¤°»ò´Á¥Z¡I ©ú¤Ñ¤~Ū¦n¤£¦n¡H¦Ñ´ªººÎı®É¶¡¨ì¤F¡A¤£n¾á¤ßªÑ»ù¡A¦nªF¦è¬O¾×¤£¦íªº¡I ¥H¤W¨¥½×¤£n·í°µ§ë¸ê¨Ì¾Ú¡I |
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·|û¡Gccc10136060 µoªí®É¶¡:2017/9/12 ¤U¤È 10:59:07²Ä 569 ½g¦^À³
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¦Ñ·¨¤j,¤µ±ß¤p§Ìµo²{Nature¥Zµn¤F¤@½g¦³ÃöADI-PEG20¦åÀùªº¤å³¹ A Phase II Study of Arginine Deiminase (ADI-PEG20) in Relapsed/Refractory or Poor-Risk Acute Myeloid Leukemia Patients www.nature.com/articles/s41598-017-10542-4 ¥Ñ©ó¤p§Ì^¤å¤Î±M·~ª¾ÃѪº¤£¨¬,¶È¬Ý¥X¨ä¤¤¤@¦W§@ªÌ¬O°ê½Ã°|Àù¬ã©Ò³¯¥ß©v©Òªø, ¤Î¦³2¦ì¯f¤HCR,¨ä¾l¤å³¹¤º®e¤p§ÌµLªk¸ÑŪ,¥i§_½Ð¦Ñ·¨¤jÀ°¤p§Ì¸Ñ´b,·PÁÂ! |
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·|û¡GKen10030885 µoªí®É¶¡:2017/9/12 ¤U¤È 10:46:57²Ä 568 ½g¦^À³
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·|û¡G¤@¤ô´H10144832 µoªí®É¶¡:2017/9/12 ¤U¤È 06:08:23²Ä 567 ½g¦^À³
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ºK¿ý¾ã²z¸ê®Æ¦p¤U¨Ñ°Ñ¡G ¡¶¤é´Á¡¹¦¨¥æªÑ¼Æ¡»¥þÅé¨é°Ó¨C¤é®w¦s¼W´îªÑ¼Æ¡´¥þÅé¨é°Ó¨C¤é®w¦sÁ`ªÑ¼Æ ¡¶2017/09/12¡¹1,749,776¡»161,313¡´33,746,669 ¡]¥H¤W¼Æ¾Ú¦p¦³¿ù»~¤§³B¡A½Ð¦U¦ì§ë¸ê¤j¤j¦h¦h¥]²[¨Ã¤£§[´f¤©½ç±Ð¡C¡^ |
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·|û¡G¸Û«H¦ó®¬10139574 µoªí®É¶¡:2017/9/12 ¤U¤È 04:56:30²Ä 566 ½g¦^À³
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§O·Q¤Ó¦h¤F¡A³o¤G¤Ñ·|¶]ªº´²¤á³£¥ý¶]¤F¡A ¥H«e¦b¸Îªü¤]¬O¡AÁÙ¦³¶W¯Å°ª¤â§õô³Q¬~±¼¡A±q¦¹®ø¥¢¡A §@µu½u¤£¬O¤Úµá¯SP´Iªº¤âªk¡A»P¨ä°µµu½u³g¤p§Q¡Aˤ£¦p¤£¶R¡A¤£©ÈÁ«¥»¡C ³æÁu®Öã§_¡A¼vÅTµu®É¶¡ªºº¦¶Õ¡C¨S¦³¨ì¤âÃÄÃÒ«e¡A½Í¨ÖÁÊ¥u¬OÓ¯«¸Ü¡C |
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