Abstract | BACKGROUND/PURPOSE: METHODS AND RESULTS: The aim of this trial is to evaluate the efficacy and safety of the regimen and to determine whether the regimen should be compared with the current standard regimen, GC, in a subsequent phase III trial for patients with unresectable or recurrent biliary tract cancer. Six patients in the phase I study and a total of 100 patients in the phase II study will be accrued over a 2-year period. The patients in the phase II study will be randomized at a 2:1 ratio to receive GC either with or without WT1 peptide vaccine. The primary endpoint of the phase II study is the 1-year overall survival rate. CONCLUSIONS:
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Authors | Takuji Okusaka, Makoto Ueno, Tosiya Sato, Yuji Heike |
Journal | Journal of hepato-biliary-pancreatic sciences
(J Hepatobiliary Pancreat Sci)
Vol. 19
Issue 4
Pg. 314-8
(Jul 2012)
ISSN: 1868-6982 [Electronic] Japan |
PMID | 22273718
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antimetabolites, Antineoplastic
- Antineoplastic Agents
- Cancer Vaccines
- Cell Cycle Proteins
- Nuclear Proteins
- RNA Splicing Factors
- Vaccines, Subunit
- WTAP protein, human
- Deoxycytidine
- Cisplatin
- Gemcitabine
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Topics |
- Antimetabolites, Antineoplastic
(therapeutic use)
- Antineoplastic Agents
(therapeutic use)
- Biliary Tract Neoplasms
(drug therapy, therapy)
- Cancer Vaccines
(therapeutic use)
- Cell Cycle Proteins
- Cisplatin
(administration & dosage, therapeutic use)
- Combined Modality Therapy
- Deoxycytidine
(administration & dosage, analogs & derivatives, therapeutic use)
- Digestive System Neoplasms
(drug therapy, therapy)
- Drug Therapy, Combination
- Female
- Humans
- Male
- Nuclear Proteins
- Pancreatic Neoplasms
(drug therapy, therapy)
- RNA Splicing Factors
- Research Design
- Treatment Outcome
- Vaccines, Subunit
(therapeutic use)
- Gemcitabine
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