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:8528511
- 负责人:
- 金额:$ 121.48万
- 依托单位:
- 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 2016-08-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAntineoplastic AgentsBioinformaticsBiologicalBiological FactorsBiological MarkersBiometryBotanicalsChemicalsChemotherapy-Oncologic ProcedureChinese HerbsClinicalClinical InvestigatorClinical ResearchClinical TrialsColorectal CancerComplexComputing MethodologiesCyclic GMPDataDevelopmentDiarrheaDoctor of MedicineDoctor of PhilosophyDouble-Blind MethodEnsureFingerprintFoundationsGene ExpressionGoalsGrantHerbal MedicineHumanMalignant NeoplasmsMediatingMedicineMethodologyMethodsMiningNatureNausea and VomitingNormal tissue morphologyPHY 906PatientsPharmacodynamicsPhasePlacebo ControlPlacebo EffectPlacebosPlasmaPreparationProceduresProcessProgram Research Project GrantsProgression-Free SurvivalsQuality ControlQuality of lifeRandomizedRegulationResearch DesignResearch PersonnelRoleSafetySeriesSiteStatistical MethodsSystems BiologyTestingTopoisomerase-I InhibitorToxic effectTreatment Protocolsarmbasecancer therapychemokinechemotherapyclinical efficacycohesioncytokinedata miningdesignexperiencehealth related quality of lifeimprovedin vivoinnovationinterdisciplinary approachirinotecanmeetingsmetastatic colorectalnoveloxaliplatinphase 2 studyplacebo controlled studypreclinical studyprogramsresponsestandard of caretooltumor
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.
这是一份修订后的临床和预防为基础的跨学科计划项目资助申请,题为“中草药作为癌症化疗的新范式”。本项目的PI是Yung-chi Cheng博士,他是项目二的导演他与其他两位知名的项目负责人Edward Chu,M.D.(项目1),他还担任Co-P. l。和赵洪宇博士(项目3)。这3个项目由一个行政核心(核心A)和一个分析核心(核心B)支助。在这个应用中,我们建议调查PHY 906,一种在东方已经使用了近2000年的中草药。我们的团队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)指纹图谱方法,以确保质量控制和批制备的一致性。使用高质量cGMP材料,我们计划进行一项随机、双盲、安慰剂对照研究,其中将在二线环境中测试PHY 906与拓扑异构酶I抑制剂伊立替康(CPT-11)组合用于mCRC患者。在项目1中,朱博士将研究PHY 906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,可用于预测PHY 906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的翻译数据,目的是确定与PHY 906对CPT-11毒性的细胞保护作用和/或PHY 906对CPT-11化疗临床疗效的调节作用相关的预测生物标志物,如项目1中提出的研究所确定的。为确保该方案的密切互动和凝聚力,已经建立了若干机制,其中包括项目领导人每月会议、年度务虚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(0)
专著数量(0)
科研奖励数量(0)
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YUNG-CHI CHENG其他文献
YUNG-CHI CHENG的其他文献
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{{ truncateString('YUNG-CHI CHENG', 18)}}的其他基金
Chinese Herbal Medicine as a Novel Paradigm for Cancer Chemotherapy
中草药作为癌症化疗的新范例
- 批准号:
8175586 - 财政年份:2011
- 资助金额:
$ 121.48万 - 项目类别:
Characterization of Predictive Biomarkers for the Clinical Efficacy of PHY906
PHY906 临床疗效的预测生物标志物的表征
- 批准号:
8920509 - 财政年份:2011
- 资助金额:
$ 121.48万 - 项目类别:
Characterization of Predictive Biomarkers for the Clinical Efficacy of PHY906
PHY906 临床疗效的预测生物标志物的表征
- 批准号:
8555271 - 财政年份:2011
- 资助金额:
$ 121.48万 - 项目类别:
Chinese Herbal Medicine as a Novel Paradigm for Cancer Chemotherapy
中草药作为癌症化疗的新范例
- 批准号:
8727468 - 财政年份:2011
- 资助金额:
$ 121.48万 - 项目类别:
Chinese Herbal Medicine as a Novel Paradigm for Cancer Chemotherapy
中草药作为癌症化疗的新范例
- 批准号:
8333321 - 财政年份:2011
- 资助金额:
$ 121.48万 - 项目类别:
Chinese Herbal Medicine as a Novel Paradigm for Cancer Chemotherapy
中草药作为癌症化疗的新范例
- 批准号:
9146289 - 财政年份:2011
- 资助金额:
$ 121.48万 - 项目类别:
Chinese Herbal Medicine as a Novel Paradigm for Cancer Chemotherapy
中草药作为癌症化疗的新范例
- 批准号:
8920507 - 财政年份:2011
- 资助金额:
$ 121.48万 - 项目类别:
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