Clinical Trial Results
临床试验结果


国际期刊《肿瘤学家》杂志旗下Clinical Trial Results (CTR)平台以共享成果,助力科研为使命。基于每个临床试验,不论其最终结果如何,都会给研究者带来获益的信念,《肿瘤学家》杂志致力于领衔建立共享平台以发布所有临床试验结果。

我们邀请您探索本期精选的CTR,共享成果,助力科研。从新药的I期可行性临床试验到对联合治疗方案的有效性和耐受性进行研究的大样本II期临床试验,CTR对不同的治疗方案提供有益的见解,这些方案有些成功了,有些失败了,但他们都对未来研究有所裨益。

Clinical Trial Results (CTR) from The Oncologist promotes the mission of sharing results to speed discoveries. Motivated by the belief that every trial, regardless of outcome, can have a benefit to the research community, The Oncologist has taken a leadership role in providing a forum for the publication of all trials.

We invite you to explore this selection of Clinical Trial Results published in support of this mission. From phase I feasibility studies of novel agents to larger-scale phase II trials studying efficacy and tolerability of combination therapies, CTR offers helpful insights into a variety of therapeutic approaches, some successful, others not, but all of which can inform future research.

Submit your own CTR at http://clinicaltrialresults.theoncologist.com.



Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck
Vanessa Trieu, Harlan Pinto, Jonathan W. Riess, Ruth Lira, Richard Luciano, Jessie Coty, Derek Boothroyd, A. Dimitrios Colevas
The Oncologist first published on March 14, 2018; doi:10.1634/theoncologist.2017-0618
http://theoncologist.alphamedpress.org/content/early/2018/03/14/theoncologist.2017-0618.abstract

A First‐in‐Human Phase 1 Study of OPB‐111077, a Small‐Molecule STAT3 and Oxidative Phosphorylation Inhibitor, in Patients with Advanced Cancers
Anthony Tolcher, Keith Flaherty, Geoffrey I. Shapiro, Jordan Berlin, Thomas Witzig, Thomas Habermann, Andrea Bullock, Edwin Rock, Agnes Elekes, Chester Lin, Dusan Kostic, Naoto Ohi, Drew Rasco, Kyriakos P. Papadopoulos, Amita Patnaik, Lon Smith, Gregory M. Cote
The Oncologist first published on March 6, 2018; doi:10.1634/theoncologist.2017-0325
http://theoncologist.alphamedpress.org/content/early/2018/03/05/theoncologist.2017-0325.abstract

A Phase II Trial of Selinexor, an Oral Selective Inhibitor of Nuclear Export Compound, in Abiraterone‐ and/or Enzalutamide‐Refractory Metastatic Castration‐Resistant Prostate Cancer
Xiao X. Wei, Adam P. Siegel, Rahul Aggarwal, Amy M. Lin, Terence W. Friedlander, Lawrence Fong, Won Kim, Mirela Louttit, Emily Chang, Li Zhang, Charles J. Ryan
The Oncologist first published on February 27, 2018; doi:10.1634/theoncologist.2017-0624
http://theoncologist.alphamedpress.org/content/early/2018/02/27/theoncologist.2017-0624.abstract

A Phase II Study of Tumor Ablation in Patients with Metastatic Sarcoma Stable on Chemotherapy
Angela C. Hirbe, Jack Jennings, Nael Saad, Joseph D. Giardina, Yu Tao, Jingqin Luo, Shellie Berry, Jacqui Toeniskoetter, Brian A. Van Tine
The Oncologist first published on February 27, 2018; doi:10.1634/theoncologist.2017-0536
http://theoncologist.alphamedpress.org/content/early/2018/02/22/theoncologist.2017-0536.abstract

Temozolomide Plus Bevacizumab in Elderly Patients with Newly Diagnosed Glioblastoma and Poor Performance Status: An ANOCEF Phase II Trial (ATAG)
Germán Reyes‐Botero, Stéphanie Cartalat‐Carel, Olivier L. Chinot, Maryline Barrie, Luc Taillandier, Patrick Beauchesne, Isabelle Catry‐Thomas, Jérôme Barrière, Jean‐Sebastien Guillamo, Michel Fabbro, Didier Frappaz, Alexandra Benouaich‐Amiel, Emilie Le Rhun, Chantal Campello, Isabelle Tennevet, François Ghiringhelli, Marie‐Laure Tanguy, Karima Mokhtari, Jérôme Honnorat, Jean‐Yves Delattre
The Oncologist first published on February 22, 2018; doi:10.1634/theoncologist.2017-0689
http://theoncologist.alphamedpress.org/content/early/2018/02/22/theoncologist.2017-0689.abstract

Pantoprazole, an Inhibitor of the Organic Cation Transporter 2, Does Not Ameliorate Cisplatin‐Related Ototoxicity or Nephrotoxicity in Children and Adolescents with Newly Diagnosed Osteosarcoma Treated with Methotrexate, Doxorubicin, and Cisplatin
Elizabeth Fox, Kristin Levin, Yan Zhu, Blair Segers, Naomi Balamuth, Richard Womer, Rochelle Bagatell, Frank Balis
The Oncologist first published on February 14, 2018; doi:10.1634/theoncologist.2018-0037
http://theoncologist.alphamedpress.org/content/early/2018/02/14/theoncologist.2018-0037.abstract

Randomized Phase II Trial of Parsatuzumab (Anti‐EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First‐Line Nonsquamous Non‐Small Cell Lung Cancer
Joachim von Pawel, David R. Spigel, Thomas Ervin, György Losonczy, Fabrice Barlesi, Erzsébet Juhász, Maria Anderson, Bruce McCall, Eric Wakshull, Priti Hegde, Weilan Ye, Daniel Chen, Ilsung Chang, Ina Rhee, Martin Reck
The Oncologist first published on February 7, 2018; doi:10.1634/theoncologist.2017-0690
http://theoncologist.alphamedpress.org/content/early/2018/02/07/theoncologist.2017-0690.abstract

A Phase I Dose‐Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low‐Grade or Intermediate‐Grade B‐Cell or T‐Cell Lymphoma
Francine Marie Foss, Terri Parker
The Oncologist first published on February 7, 2018; doi:10.1634/theoncologist.2017-0658
http://theoncologist.alphamedpress.org/content/early/2018/02/07/theoncologist.2017-0658.abstract

Single Arm, Phase II Study of Cisplatin, Docetaxel, and Erlotinib in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas
William N. William, Jr., Anne S. Tsao, Lei Feng, Lawrence E. Ginsberg, J. Jack Lee, Merrill S. Kies, Bonnie S. Glisson, Edward S. Kim
The Oncologist first published on January 25, 2018; doi:10.1634/theoncologist.2017-0661
http://theoncologist.alphamedpress.org/content/early/2018/01/25/theoncologist.2017-0661.abstract

帕尼单抗在RAS野生型转移性小肠或肝胰管壶腹部腺癌中的II期研究
Phase II Study of Panitumumab in RAS Wild‐Type Metastatic Adenocarcinoma of Small Bowel or Ampulla of Vater

Pat Gulhati, Kanwal Raghav, Rachna Shroff, Gauri Varadhachary, Milind Javle, Wei Qiao, Huamin Wang, Jeffrey Morris, Robert Wolff, Michael J. Overman
The Oncologist 2018; 23:277-e26; first published on December 19, 2017; doi:10.1634/theoncologist.2017-0568
http://theoncologist.alphamedpress.org/content/23/3/277.abstract.zh

局部晚期胰腺癌患者经新辅助GTX联合或不联合放射治疗的结局和生存期的预测因子
Predictors of Response and Survival in Locally Advanced Adenocarcinoma of the Pancreas Following Neoadjuvant GTX with or Without Radiation Therapy

William H. Sherman, Elizabeth Hecht, David Leung, Kyung Chu
The Oncologist 2018; 23:4-e10; first published on December 6, 2017; doi:10.1634/theoncologist.2017-0208
http://theoncologist.alphamedpress.org/content/23/1/4.abstract.zh

奥沙利铂、卡培他滨和塞来昔布联合同步放疗治疗新诊断的可切除直肠癌患者的II期研究
Phase II Trial Using a Combination of Oxaliplatin, Capecitabine, and Celecoxib with Concurrent Radiation for Newly Diagnosed Resectable Rectal Cancer

Emilio P. Araujo‐Mino, Yehuda Z. Patt, Cristina Murray‐Krezan, Joshua A. Hanson, Pranshu Bansal, Ben J. Liem, Ashwani Rajput, M. Houman Fekrazad, Glenory Heywood, Fa Chyi Lee
The Oncologist 2018; 23:2-e5; first published on November 20, 2017; doi:10.1634/theoncologist.2017-0474
http://theoncologist.alphamedpress.org/content/23/1/2.abstract.zh

Necuparanib联合白蛋白结合型紫杉醇与吉西他滨治疗转移性胰腺癌患者的安全性、药代动力学、药效学和抗肿瘤活性: I期研究结果
Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Necuparanib Combined with Nab‐Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer: Phase I Results

Eileen M. O'Reilly, James Roach, Paul Miller, Kenneth H. Yu, Catherine Tjan, Molly Rosano, Silva Krause, William Avery, Julie Wolf, Keith Flaherty, Darrell Nix, David P. Ryan
The Oncologist 2017; 22:1429-e139; first published on November 20, 2017; doi:10.1634/theoncologist.2017-0472
http://theoncologist.alphamedpress.org/content/22/12/1429.abstract.zh

一项吉西他滨和白蛋白结合型紫杉醇联合apatorsen或安慰剂治疗转移性胰腺癌的随机、双盲、II期试验:RAINIER试验
A Randomized, Double‐Blinded, Phase II Trial of Gemcitabine and Nab‐Paclitaxel Plus Apatorsen or Placebo in Patients with Metastatic Pancreatic Cancer: The RAINIER Trial

Andrew H. Ko, Patrick B. Murphy, James D. Peyton, Dianna L. Shipley, Ahmed Al‐Hazzouri, Francisco A. Rodriguez, Mark S. Womack IV, Henry Q. Xiong, David M. Waterhouse, Margaret A. Tempero, Shuangli Guo, Cassie M. Lane, Chris Earwood, Laura M. DeBusk, Johanna C. Bendell
The Oncologist 2017; 22:1427-e129; first published on September 21, 2017; doi:10.1634/theoncologist.2017-0066
http://theoncologist.alphamedpress.org/content/22/12/1427.abstract.zh

5-氟尿嘧啶(5-FU)、奥沙利铂和拉帕替尼联合放疗的新辅助疗法用于局部人表皮生长受体2(HER2)阳性食管胃交界处腺癌患者的导入安全性队列的II期研究
A Phase II Study with Lead‐In Safety Cohort of 5‐Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2‐Positive Esophagogastric Adenocarcinomas

Gregg Shepard, Edward R. Arrowsmith, Patrick Murphy, John H. Barton, Jr., James D. Peyton, Mark Mainwaring, Laura Blakely, Noel A. Maun, Johanna C. Bendell
The Oncologist 2017; 22:1152-e98; first published on August 1, 2017; doi:10.1634/theoncologist.2017-0186
http://theoncologist.alphamedpress.org/content/22/10/1152.abstract.zh

索拉非尼联合卡培他滨治疗肝细胞癌患者的II期试验:INST 08-20
Phase II Trial of Sorafenib in Combination with Capecitabine in Patients with Hepatocellular Carcinoma: INST 08‐20

Yehuda Patt, Cristhiam Rojas‐Hernandez, Houman Mohammad Fekrazad, Pranshu Bansal, Fa Chyi Lee
The Oncologist 2017; 22:1156-e111; first published on July 7, 2017; doi:10.1634/theoncologist.2017-0236
http://theoncologist.alphamedpress.org/content/22/10/1158.abstract.zh

培美曲塞延时输注联合吉西他滨治疗难治性转移性结直肠癌:临床前依据和II期研究结果
Prolonged Pemetrexed Infusion Plus Gemcitabine in Refractory Metastatic Colorectal Cancer: Preclinical Rationale and Phase II Study Results

Alessandro Passardi, Francesca Fanini, Livia Turci, Flavia Foca, Paola Rosetti, Silvia Ruscelli, Andrea Casadei Gardini, Martina Valgiusti, Claudio Dazzi, Maurizio Marangolo
The Oncologist 2017; 22:886-e79; first published on June 7, 2017; doi:10.1634/theoncologist.2017-0206
http://theoncologist.alphamedpress.org/content/22/8/886.abstract.zh

晚期肝细胞癌患者中Trebananib联合索拉非尼一线治疗的II期研究
Phase II Study of First‐Line Trebananib Plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma

Ghassan K. Abou‐Alfa, Jean‐Frederic Blanc, Steven Miles, Tom Ganten, Jörg Trojan, Jonathan Cebon, Andre K. Liem, Lara Lipton, Charu Gupta, Benjamin Wu, Michael Bass, Ellen Hollywood, Jennifer Ma, Margaret Bradley, Jason Litten, Leonard B. Saltz
The Oncologist 2017; 22:780-e65; first published on June 7, 2017; doi:10.1634/theoncologist.2017-0058
http://theoncologist.alphamedpress.org/content/22/7/780.abstract.zh

Ramucirumab治疗中国晚期实体瘤患者的I期剂量递增研究
Phase I Dose-Escalation Study of Ramucirumab in Chinese Patients with Advanced Solid Tumors

Junning Cao, Dongmei Ji, Zhiyu Chen, Weina Shen, Jin Wang, Baoyue Li, Haidong Chi, Amanda Long, Ling Gao, Jin Li
The Oncologist 2017; 22:638-e56; first published on May 2, 2017; doi:10.1634/theoncologist.2017-0137
http://theoncologist.alphamedpress.org/content/22/6/638.abstract.zh

索拉非尼(BAY 43-9006)治疗卡波西肉瘤患者的Ib期研究
A Phase Ib Study of Sorafenib (BAY 43-9006) in Patients with Kaposi Sarcoma

Thomas S. Uldrick, Priscila H. Goncalves, Kathleen M. Wyvill, Cody J. Peer, Wendy Bernstein, Karen Aleman, Mark N. Polizzotto, David Venzon, Seth M. Steinberg, Vickie Marshall, Denise Whitby, Richard F. Little, John J. Wright, Michelle A. Rudek, William D. Figg, Robert Yarchoan
The Oncologist 2017; 22:505-e49; first published on March 24, 2017; doi:10.1634/theoncologist.2016-0486
http://theoncologist.alphamedpress.org/content/22/5/505.abstract.zh