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Chinese Herbal Medicine as a Novel Paradigm for Cancer Chemotherapy

中草药作为癌症化疗的新范例

基本信息

批准号：
9146289
负责人：
YUNG-CHI CHENG
金额：
$ 87.78万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-15 至 2018-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9146289
关键词：
Address Antineoplastic Agents Bioinformatics Biological Biological Markers Biometry Botanicals Camptothecin-11 Chemicals Chemotherapy-Oncologic Procedure Chinese Herbs Clinical Clinical Investigator Clinical Research Clinical Trials Colorectal Cancer Complex Computing Methodologies Cyclic GMP Data Development Diarrhea Doctor of Medicine Doctor of Philosophy Double-Blind Method Ensure Fingerprint Foundations Gene Expression Goals Grant Herbal Medicine Human Malignant Neoplasms Mediating Medicine Methodology Methods Mining Natural Products Nature Nausea and Vomiting Normal tissue morphology PHY 906 Patients Phase Placebo Control Placebo Effect Placebos Plasma Preparation Procedures Process Program Research Project Grants Progression-Free Survivals Quality Control Quality of life Randomized Regulation Research Design Research Personnel Role Safety Series Site Statistical Methods Systems Biology Testing Topoisomerase-I Inhibitor Toxic effect Treatment Protocols arm base cancer therapy chemokine chemotherapy clinical efficacy cohesion cytokine data mining design experience health related quality of life improved in vivo innovation interdisciplinary approach irinotecan meetings metastatic colorectal novel oxaliplatin patient subsets pharmacodynamic biomarker phase 2 study placebo controlled study preclinical study predictive marker programs response standard of care tool tumor

项目摘要

This is a revised clinical- and translational-based interdisciplinary Program Project Grant application entitled "Chinese Herbal Medicine as a Novel Paradigm for Cancer Chemotherapy". The Pl of this Program is Yung-chi Cheng, Ph.D., and he directs Project 2. He is joined two other well-established Project leaders, Edward Chu, M.D. (Project 1), who also serves as Co-P.l. of the Program, and Hongyu Zhao, Ph.D. (Project 3). These 3 Projects are supported by an Administrative Core (Core A) and an Analytical Core (Core B). In this application, we propose to investigate PHY906, a Chinese herbal medicine that has been used in the Orient for nearly 2000 years. Our group has developed a rigorous standard operating procedure to produce cGMP material as well as develop highly sensitive chemical (LC-MS) and biological (gene expression) fingerprinting methodologies to ensure quality control and consistency of batch preparation. Using high quality cGMP material, we plan to conduct a randomized, double-blind, placebo-controlled study where PHY906 will be tested in combination with the topoisomerase I inhibitor irinotecan (CPT-11) in patients with mCRC in the 2nd- line setting. In Project 1, Dr. Chu will investigate the effect of PHY906 on the safety, health-related quality of life, and clinical efficacy of CPT-11 monotherapy. In Project 2, Dr. Cheng will conduct an extensive series of biomarker analyses to identify the potential pharmacodynamic markers that can be used to predict for the clinical activity and efficacy of PHY906 when used in combination with CPT-11. In Project 3, Dr. Zhao will develop novel bioinformatic and computational methodologies to mine the translational data coming from Project 2 with the goal of identifying the predictive biomarkers that are associated with either the cytoprotective effects of PHY906 on CPT-11 toxicity and/or the modulatory effects of PHY906 on clinical efficacy of CPT-11 chemotherapy, as determined by the studies proposed in Project 1. Several mechanisms are in place to ensure the close interaction and cohesion of the Program, and these include monthly meetings of the Project leaders, an annual retreat, and an internal advisory board to provide guidance and advice.

这是一份修订后的以临床和翻译为基础的跨学科项目资助申请，题为“中草药作为癌症化疗的新范式”。项目负责人为郑永智博士，主持项目二。他加入了另外两位知名的项目负责人，Edward Chu，医学博士（项目1），他也担任Co-P.l。赵宏宇博士（项目3）。这三个项目由行政核心（核心A）和分析核心（核心B）支持。在这个申请中，我们建议研究PHY906，一种在东方已经使用了近2000年的中草药。我们制定了严格的标准操作程序来生产cGMP材料，并开发了高灵敏度的化学（LC-MS）和生物（基因表达）指纹识别方法，以确保批量制备的质量控制和一致性。使用高质量的cGMP材料，我们计划进行一项随机、双盲、安慰剂对照研究，其中PHY906将与拓扑异构酶I抑制剂伊立替康（CPT-11）联合在二线mCRC患者中进行测试。在项目1中，朱博士将研究PHY906对CPT-11单药治疗的安全性、健康相关生活质量和临床疗效的影响。在项目2中，郑博士将进行一系列广泛的生物标志物分析，以确定潜在的药效学标志物，这些标志物可用于预测PHY906与CPT-11联合使用时的临床活性和疗效。在项目3中，赵博士将开发新的生物信息学和计算方法来挖掘来自项目2的转化数据，目的是确定与项目1中提出的研究确定的PHY906对CPT-11毒性的细胞保护作用和/或PHY906对CPT-11化疗临床疗效的调节作用相关的预测性生物标志物。建立了若干机制，以确保该计划的密切互动和凝聚力，其中包括项目领导人的月度会议、年度务静会和提供指导和建议的内部咨询委员会。

项目成果

期刊论文数量（13）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

The number of intestinal bacteria is not critical for the enhancement of antitumor activity and reduction of intestinal toxicity of irinotecan by the Chinese herbal medicine PHY906 (KD018).

DOI：
10.1186/1472-6882-14-490
发表时间：
2014-12-15
期刊：
BMC complementary and alternative medicine
影响因子：
0
作者：
Lam W;Jiang Z;Guan F;Hu R;Liu SH;Chu E;Cheng YC
通讯作者：
Cheng YC

Targeting tumour microenvironment by tyrosine kinase inhibitor.

DOI：
10.1186/s12943-018-0800-6
发表时间：
2018-02-19
期刊：
Molecular cancer
影响因子：
37.3
作者：
Tan HY;Wang N;Lam W;Guo W;Feng Y;Cheng YC
通讯作者：
Cheng YC

Study of Malformin C, a Fungal Source Cyclic Pentapeptide, as an Anti-Cancer Drug.

真菌源环状五肽 Malformin C 作为抗癌药物的研究。

DOI：
10.1371/journal.pone.0140069
发表时间：
2015
期刊：
PloS one
影响因子：
3.7
作者：
Wang,Jing;Jiang,Zaoli;Lam,Wing;Gullen,ElizabethA;Yu,Zhe;Wei,Ying;Wang,Lihui;Zeiss,Caroline;Beck,Amanda;Cheng,Ee-Chun;Wu,Chunfu;Cheng,Yung-Chi;Zhang,Yixuan
通讯作者：
Zhang,Yixuan

Safety surveillance of traditional Chinese medicine: current and future.