Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol.

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Yoshihiro Miyasaka, Takao Ohtsuka, Susumu Eguchi, Masafumi Inomata, Kazuyoshi Nishihara, Hiroyuki Shinchi, Koji Okuda, Hideo Baba, Hiroaki Nagano, Toshiharu Ueki, Hirokazu Noshiro, Masafumi Nakamura
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引用次数: 2

Abstract

Introduction: Although neoadjuvant treatment is recommended for patients with borderline resectable pancreatic cancer (BRPC), no standard neoadjuvant regimen has been established for BRPC with arterial involvement (BRPC-A), which is associated with a higher risk of margin-positive resection and poorer prognosis than BRPC with only venous involvement. Gemcitabine plus nab-paclitaxel (GnP) has been reported to significantly reduce tumor size in metastatic pancreatic cancer, and some retrospective studies suggested that neoadjuvant GnP for BRPC improved resectability and survival.

Methods and analysis: A prospective multicenter single-arm phase II study is conducted to evaluate the safety and efficacy of GnP as neoadjuvant chemotherapy for BRPC-A. The primary endpoint is the R0 resection rate. The secondary endpoints are the neoadjuvant chemotherapy response rate, resection rate, pathological response rate, incidence rate of adverse events, and quality of life.

Ethics and dissemination: This study protocol was approved by the institutional review board of Kyushu University (no. 181). The results will be published in a peer-reviewed journal and will be presented at medical meetings.

Highlights: Strategy for borderline resectable pancreatic cancer involving arteries (BRPC-A).There is no standard regimen for neoadjuvant chemotherapy for BRPC-A.Gemcitabine plus nab-paclitaxel (GnP) shows significant tumor shrinkage.Neoadjuvant GnP for BRPC-A increases resectability and margin-negative resection.

吉西他滨加nab -紫杉醇新辅助化疗方案治疗伴有动脉受损伤的边缘可切除胰腺癌:一项前瞻性多中心单组II期研究方案
虽然推荐对交界性可切除胰腺癌(BRPC)患者进行新辅助治疗,但对于动脉受累的BRPC (BRPC- a)尚未建立标准的新辅助治疗方案,与仅静脉受累的BRPC相比,BRPC的边缘阳性切除风险更高,预后更差。据报道,吉西他滨加nab-紫杉醇(GnP)可显著降低转移性胰腺癌的肿瘤大小,一些回顾性研究表明,BRPC的新辅助GnP可提高可切除性和生存率。方法与分析:通过一项前瞻性多中心单臂II期研究来评估GnP作为BRPC-A新辅助化疗的安全性和有效性。主要终点是R0切除率。次要终点为新辅助化疗反应率、切除率、病理反应率、不良事件发生率和生活质量。伦理与传播:本研究方案已获得九州大学机构审查委员会批准(编号:014861)。181)。研究结果将发表在同行评议的期刊上,并将在医学会议上发表。重点:浸润动脉的交界性可切除胰腺癌(BRPC-A)的治疗策略。BRPC-A的新辅助化疗没有标准方案。吉西他滨联合nab-紫杉醇(GnP)显示肿瘤明显缩小。BRPC-A的新辅助GnP增加了可切除性和边缘阴性切除。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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