https://scholars.lib.ntu.edu.tw/handle/123456789/461667
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.author | CHUN-JEN LIU | en_US |
dc.contributor.author | PO-HUANG LEE | en_US |
dc.contributor.author | Lin D.-Y. | en_US |
dc.contributor.author | Wu C.-C. | en_US |
dc.contributor.author | Jeng L.-B. | en_US |
dc.contributor.author | Lin P.-W. | en_US |
dc.contributor.author | Mok K.-T. | en_US |
dc.contributor.author | Lee W.-C. | en_US |
dc.contributor.author | Yeh H.-Z. | en_US |
dc.contributor.author | MING-CHIH HO | en_US |
dc.contributor.author | Yang S.-S. | en_US |
dc.contributor.author | Lee C.-C. | en_US |
dc.contributor.author | Yu M.-C. | en_US |
dc.contributor.author | REY-HENG HU | en_US |
dc.contributor.author | Peng C.-Y. | en_US |
dc.contributor.author | Lai K.-L. | en_US |
dc.contributor.author | Chang S.S.-C. | en_US |
dc.contributor.author | PEI-JER CHEN | en_US |
dc.creator | Liu C.-J.;Lee P.-H.;Lin D.-Y.;Wu C.-C.;Jeng L.-B.;Lin P.-W.;Mok K.-T.;Lee W.-C.;Yeh H.-Z.;Ming-Chih Ho;Yang S.-S.;Lee C.-C.;Yu M.-C.;Hu R.-H.;Peng C.-Y.;Lai K.-L.;Chang S.S.-C.;Chen P.-J. | - |
dc.date.accessioned | 2020-02-19T09:33:57Z | - |
dc.date.available | 2020-02-19T09:33:57Z | - |
dc.date.issued | 2009 | - |
dc.identifier.issn | 0168-8278 | - |
dc.identifier.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84984569951&doi=10.1016%2fj.jhep.2008.12.023&partnerID=40&md5=216d251a9678ba022249dadcf8cbdd4b | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/461667 | - |
dc.description.abstract | Background/Aims: Hepatocellular carcinoma recurrence after curative treatment adversely influences clinical outcome. It is important to explore adjuvant therapies. This phase II/stage 1 multi-center, randomized trial investigated the safety, optimal dosage and preliminary efficacy of PI-88, a novel heparanase inhibitor, in the setting of post-operative recurrence of HCC according to a Simon's 2-stage design. Methods: Three groups were included: one untreated arm (Group A) and two PI-88 arms (Group B: 160 mg/day; Group C: 250 mg/day). Treatment groups received PI-88 over nine 4-week treatment cycles, followed by a 12-week treatment-free period. Safety and optimal dosage were assessed. Results: Overall, 172 patients were randomized and 168 were included in the intention-to-treat (ITT) population. Treatment-related adverse effects included cytopenia, injection site hemorrhage, PT prolongation, etc. Four serious adverse events were possibly related to PI-88 treatment. One (1.8%) group B patients and six (10.5%) group C had hepatotoxicity-related withdrawals. Among the ITT population, 29 patients (50%) in Group A, 35 (63%) in Group B, and 22 (41%) in Group C remained recurrence-free at completion. Calculated T1 value suggested 160 mg/day treatment satisfied the criteria for the next stage of the trial. Conclusions: PI-88 at 160 mg/day is optimal and safe, and shows preliminary efficacy as an adjunct therapy for post-operative HCC. ? 2009 European Association for the Study of the Liver. | - |
dc.publisher | Elsevier | - |
dc.relation.ispartof | Journal of Hepatology | - |
dc.subject.classification | [SDGs]SDG3 | - |
dc.subject.other | pi 88; placebo; acute pancreatitis; adjuvant therapy; adult; adverse outcome; alanine aminotransferase blood level; alopecia; article; aspartate aminotransferase blood level; brain hemorrhage; cancer recurrence; cancer staging; cancer surgery; clinical trial; controlled clinical trial; controlled study; cytopenia; drug dose comparison; drug efficacy; drug safety; drug tolerability; drug withdrawal; female; gingiva bleeding; human; human cell; human tissue; injection site bleeding; liver cell carcinoma; liver rupture; liver toxicity; major clinical study; male; metastasis; multicenter study; multiple cycle treatment; muscle spasm; neutropenia; outcome assessment; patient satisfaction; phase 2 clinical trial; postoperative complication; priority journal; pt prolongation; QT prolongation; randomized controlled trial; side effect; thrombocytopenia; treatment duration | - |
dc.title | Heparanase inhibitor PI-88 as adjuvant therapy for hepatocellular carcinoma after curative resection: A randomized phase II trial for safety and optimal dosage | en_US |
dc.type | journal article | en |
dc.identifier.doi | 10.1016/j.jhep.2008.12.023 | - |
dc.identifier.pmid | 19303160 | - |
dc.identifier.scopus | 2-s2.0-84984569951 | - |
dc.relation.pages | 958-968 | - |
dc.relation.journalvolume | 50 | - |
dc.relation.journalissue | 5 | - |
item.cerifentitytype | Publications | - |
item.grantfulltext | none | - |
item.fulltext | no fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_6501 | - |
item.openairetype | journal article | - |
crisitem.author.dept | Internal Medicine-NTUH | - |
crisitem.author.dept | Surgery | - |
crisitem.author.dept | Surgery-NTUH | - |
crisitem.author.dept | Surgery-NTUH | - |
crisitem.author.dept | Surgery | - |
crisitem.author.dept | Surgery-NTUHBH | - |
crisitem.author.dept | Surgery | - |
crisitem.author.dept | Surgery-NTUH | - |
crisitem.author.dept | Clinical Medicine | - |
crisitem.author.orcid | 0000-0002-6202-0993 | - |
crisitem.author.orcid | 0000-0001-5831-035X | - |
crisitem.author.orcid | 0000-0003-3660-1062 | - |
crisitem.author.orcid | 0000-0001-6709-031X | - |
crisitem.author.orcid | 0000-0001-8316-3785 | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | National Taiwan University Hospital Bei-Hu Branch | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | College of Medicine | - |
顯示於: | 醫學系 |
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