肠癌新药讨论专用链接贴

ARQ197相关链接：

http://www.yuaigongwu2012.com/thread-6799-1-1.html

Aflibercept(阿柏西普）

http://www.yuaigongwu2012.com/fo ... amp;extra=#pid82730

Axitinib(阿西替尼)相关链接：

http://www.yuaigongwu2012.com/thread-5084-1-1.html

Apatinib(阿帕替尼)相关链接：

http://www.yuaigongwu2012.com/thread-5219-1-2.html

Nintedanib(BIBF1120) 相关链接：

http://www.yuaigongwu2012.com/thread-5631-1-1.html

Cediranib(西地尼布) 相关链接：

http://www.yuaigongwu2012.com/thread-5079-1-2.html

Everolimus(伊维莫司) 相关链接：

http://www.yuaigongwu2012.com/thread-5095-1-2.html

Panitumumab(帕尼单抗) 相关链接：

http://www.yuaigongwu2012.com/thread-5072-1-2.html

Regorafenib相关链接：

http://www.yuaigongwu2012.com/thread-4942-1-2.html

Sorafenib(多吉美)相关链接：

http://www.yuaigongwu2012.com/thread-5238-1-1.html

Tarceva(特罗凯) 相关链接：

http://www.yuaigongwu2012.com/thread-5073-1-2.html

Tivozanib相关链接：

http://www.yuaigongwu2012.com/thread-6785-1-1.html

Bibw 2992
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

Cetuximab
A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer
Irinotecan, Cetuximab and Everolimus to Patients With Metastatic Colorectal Cancer
Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
FLOX in Combination With Cetuximab in First-line Treatment of Colorectal Cancer
Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
Cetuximab, Capecitabine and Oxaliplatin in Patients With Epidermal Growth Factor Receptor (EGFr) Expressing Metastatic Colorectal Cancer
A Phase II Study of Bevacizumab, Irinotecan and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer
A Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer
Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer
BAY 43-9006 Plus Cetuximab to Treat Colorectal Cancer
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

Avastin
A Study to Compare Two Avastin-Based Treatment Regimens for the Treatment of Metastatic Colorectal Cancer
Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer
TREE-2: Three Regimens of Eloxatin in Advanced Colorectal Cancer
Drug: oxaliplatin;   Drug: fluoropyrimidine;   Drug: bevacizumab
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer
Dose Dense Therapy and Bevacizumab in Solid Tumors and Colorectal Cancer
Study of Bevacizumab, Erlotinib, FOLFOX for Patients With Untreated Metastatic Colorectal Cancer
A Phase II Study of Bevacizumab, Irinotecan and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer
A New Agent DAVANAT in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
A Study to Evaluate Avastin in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

其它药物
KRAS Wild-type Metastatic Colorectal Cancer Trial
Drug: Nimotuzumab Humanized Monoclonal Antibody;   Drug: Nimotuzumab
A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer
Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer
MK-2206 and AZD6244 in Patients With Advanced Colorectal Carcinoma
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
Phase II Efficacy Study of AZD6244 in Colorectal Cancer

Erlotinib
Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer
Tarceva, Capecitabine and Oxaliplatin for Metastatic Colorectal Cancer
Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)

IRESSA
IRESSA™ In Combo With Xeloda™ in Advanced Colorectal Cancer Patients After 1st-Line Chemo Failure
Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer
Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer
Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
A Phase 2 Study of Tomudex & Iressa as Second Line Chemotherapy in Subjects With Colorectal Carcinoma
ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
Pharmocokinetic/Pharmacodynamic (PK/PD) Study of the Combination Cetuximab/Gefitinib

Regorafenib
Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in K-RAS/BRAF Mutant Metastatic Colorectal Cancer
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.
Study to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI

Chemotherapy
Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer
Drug: Celecoxib;   Drug: Capecitabine;   Drug: Irinotecan
Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer
Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced Colorectal Cancer
Drug: lapatinib;   Drug: oxaliplatin;   Drug: capecitabine
A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer
Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer
Drug: 5-fluorouracil;   Drug: leucovorin;   Drug: irinotecan;   Drug: oxaliplatin
FOLFOX Chemotherapy Regimen (5-FU, Leucovorin, Oxaliplatin) in Metastatic Colorectal Cancer
Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer
Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer
ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer

老马 发表于 2012-1-9 09:01

                               
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Bibw 2992
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 29 ...

多谢老马费心

成长的烦恼 发表于 2012-1-9 12:58

                               
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多谢老马费心

听了晴儿的美妙歌声，我得付出劳动。

老马 发表于 2012-1-9 13:03

                               
登录/注册后可看大图

听了晴儿的美妙歌声，我得付出劳动。

必须的！

Modified FOLFOX6 with oxaliplatin stop-and-go strategy and oral S-1 maintenance therapy in advanced colorectal cancer: CCOG-0704 study.
标题：改良FOLFOX6方案中采用奥沙利铂"打打停停"策略并联合口服S-1维持治疗对晚期直结肠癌的疗效：CCOG-0704研究
作者：Nakayama G, Kodera Y, Yokoyama H, Okuda N, Watanabe T, Tanaka C, Iwata N, Ohashi N, Koike M, Fujiwara M, Nakao A.
关键词：Metastatic colorectal cancer, First-line chemotherapy, Oxaliplatin, Neurotoxicity, S-1.
摘要：背景 氟尿嘧啶与四氢叶酸（5-FU/LV）联合奥沙利铂（FOLFOX）是治疗转移性直结肠癌（mCRC）的一线方案。不过，由于奥沙利铂易蓄积神经毒性，因此即使患者对治疗有反应仍需中断治疗。中断FOLFOX后，以5-FU/LV维持治疗，然后序贯FOLFOX是有效且同时可减少神经毒性的治疗模式。本研究的目的旨在评估以改良FOLFOX6（mFOLFOX6）作为mCRC一线治疗方案期间，以S-1（一种口服氟尿嘧啶衍生物）进行维持治疗在这一"打打停停"策略中的可行性。 对象与方法 30例初治mCRC患者接受6疗程的mFOLFOX6治疗，然后口服S-1维持治疗，在4个疗程或肿瘤进展后，序贯mFOLFOX6治疗。主要研究终点为疾病控制期（DDC）。 结果 30例患者中，21例对S-1维持治疗有反应或病情稳定。15例患者继续mFOLFOX6治疗。中位DDC与无进展生存期分别为9.3和7.9个月，初次mFOLFOX6治疗后，缓解率与疾病控制率分别为40.0%和86.6%，S-1维持治疗后分别为23.8%和57.1%，mFOLFOX6再治后分别为20.0%和73.3%。28例患者（93.3%）有周围神经病变，但仅有1例（3.3%）为3级神经毒性。 结论 奥沙利铂"打打停停"策略联合口服S-1维持治疗可以作为日本mCRC患者的一线治疗方案。需要进一步进行前瞻、随机对照研究。

A phase I trial of S-1 with oxaliplatin in patients with relapsed and metastatic colorectal cancer.
标题：S-1联合奥沙利铂治疗复发和转移性直结肠癌患者的I期临床试验
作者：Kim HS, Park MJ, Uhm JE, Lee Y, Lee HY, Kang EM, Lee J, Park SH, Park JO, Lim HY, Kang WK, Park YS.
关键词：Colorectal cancer, Oxaliplatin, Phase I study, S-1.
摘要：背景 S-1对直结肠癌有临床疗效，而临床前研究数据也表明，S-1与奥沙利铂在动物模型中有协同效应。本I期研究旨在检测S-1联合奥沙利铂的最大耐受剂量，并明确后续II期研究的推荐剂量。 对象与方法 初治的结直肠腺癌患者，如有可测量病灶，纳入该研究。S-1在1~14天给药，起始剂量为60 mg/（m²•天），10 mg/m²为一个增量级别。奥沙利铂以固定剂量130 mg/m²给予，在第1天静脉输注2h。每3周为一疗程。 结果 27例患者被分为6组不同的S-1剂量水平。剂量限制毒性（DLT）为中性粒细胞减少、腹泻和呕吐。在5级剂量（100 mg/m²）下，2例患者出现DLT，但第三队列则无患者发生DLT。在6级剂量（110 mg/m²>）下，2例患者有DLT，1例患者死于治疗相关毒性反应。治疗因此停止。 结论 推荐剂量为：S-1 100 mg/m²，给药1~14天，奥沙利铂130 mg/m²，第1天给药，每3周为一疗程。该方案为II期研究的推荐剂量。

Phase II Study of Combined Treatment with Irinotecan and S-1 (IRIS) in Patients with Inoperable or Recurrent Advanced Colorectal Cancer (HGCSG0302)
标题：伊立替康联合S-1（IRIS）治疗不可手术或复发性晚期结直肠癌的II期临床研究（HGCSG0302）
作者：Komatsu Y, Yuki S, Sogabe S, Fukushima H, Iwanaga I, Kudo M, Tateyama M, Meguro T, Uebayashi M, Saga A, Sakata Y, Asaka M.
关键词：Colorectal cancer, Irinotecan, Phase II study, S-1
摘要： 目的 该II期临床研究旨在评价口服氟尿嘧啶S-1联合伊立替康对既往未接受过治疗的转移性结直肠癌患者的疗效与安全性。 方法 主要研究终点为缓解率，次要研究终点为安全性、无进展生存期和中位生存期。研究纳入患者为既往未接受过治疗的不可切除晚期结直肠癌患者。伊立替康给药剂量为100 mg/m2（第1、15天），S-1（40 mg/m2）连续给药2周（第1~14天），然后停药14天。 结果 研究纳入40例患者，4例患者发生4级中性粒细胞减少，6例患者发生3级腹泻。无其他严重血液学及非血液学不良反应发生，所有患者接受以门诊为基础的IRIS方案显示出良好的安全性。缓解率为52.5%[95%可信区间（CI），36.1%~68.5%]，中位无进展生存期为8.6个月（95%CI，5.3~11.9），中位生存期为23.4个月（95%CI，15.9~30.8）。 结论 IRIS方案有较高的缓解率，且安全性较好。IRIS可成为不可手术或复发性晚期结直肠癌的一线治疗方案。

这些资料怎么看得一头雾水呀。。。。成长整理一下贴上来。。哈哈。。。

ASCO 2012：IMA910治疗晚期结直肠癌的二期临床试验数据
2012-06-05 23:30 来源：丁香园    作者：冷悦雨



COIN试验的病人配对分析发现IMA910治疗的病人有满意的总体存活时间。

T细胞对结直肠癌IMA910疫苗多肽的反应与总体存活时间长有明显的相关性。

2012-6-1，图宾根– immatics biotechnologies GmbH, 一个致力于开发能有效抗癌的治疗性疫苗的公司，今天宣布说他们的利用IMA910治疗进展期结直肠癌的II期临床试验的总体生存时间明显长于最近发表的MRC COIN III期临床试验的配对病人。Immatics研究也发现那些能对IMA910中2个或以上肿瘤相关肽类(TUMAPs)起免疫反应的病人有更长的总存活时间。这个结果今天在美国芝加哥ASCO年会上发表。IMA910是一种肿瘤疫苗，它包含13种从原发性结直肠肿瘤组织中合理选择、直接提取的TUMAPs。

IMA910 II期临床试验共纳入92个进展期/转移性结直肠癌病人，他们经过12周一线奥沙利铂为基础的方案化疗之后没有出现进展并准备中断化疗。

IMA910治疗组病人与MRC COIN 临床试验C组病人的的总体存活时间比较使用前瞻性、独立、结果盲法的配对分析。与IMA910组病人一样，COIN试验C组中的病人也是接受是以奥沙利铂为基础的一线化疗方案12周以后没有出现进展，正计划中断研究方案中周期性的化疗。采用独立、盲法、配对分析的方法是为了消除在基本特征和预后因素方面的差异，为试验的总体生存分析提供近乎一致的总体。COIN试验纳入了接近2500名病人，是到目前为止纳入进展期结直肠癌病人最多的研究，旨在评估三种不同的治疗方案的相关益处，其中一个方案采用周期性的化疗。

在immatics 的II期研究中，与IMA910治疗组病人中位存活时间是19.7月相比，配对的COIN试验中开始就使用一线化疗方案的病人的中位存活时间16.5月。危害比（HR）是0.0665(p=0.0386)。IMA910治疗组病人也有较高的1年生存率(69% vs 55%)和2年存活率(40% vs 24%)。

另外，像前面两个immatics临床试验（IMA910治疗肾细胞癌）一样，这个试验证明病人有可检测到的T细胞对2种或以上TUMAPs的免疫反应，也叫做多肽应答，免疫应答和临床结果有明显的相关性。在这个研究中不论多肽应答的类型如何，与配对的COIN试验病人相比，对IMA910的多肽应答与临床更长的整体存活有关（多肽CD8 T细胞应答 vs. COIN HR 0.53, p=0.038，多肽 CD4 T细胞应答 vs. COIN HR 0.53, p=0.016，联合多肽CD8 和 CD4 应答HR 0.45, p=0.04）。当没有多肽应答是与配对的COIN病人具有相似的存活时间。

牛津大学临床肿瘤学教授、MRC/CR-UK Gray协会主任、COIN试验首席专家Tim Maughan教授说：“从IMA910 II期试验中获得的总体存活时间的数据是令人振奋的。对COIN试验亚组病人周期性的化疗的盲法、配对分析为评估本研究的总体生存终点产生了一个非常具有可比性的病人总体。我相信这个完美的结果将保证未来IMA910治疗结直肠癌病人临床发展”。

这个II期临床试验也发现IMA910耐受性良好，中度的注射位置反应是最常见的副作用。

Immatics 的CEO Paul Higham说：“与配对的COIN研究的病人相比，总体生存时间的提高是非常鼓舞人心的。重要的是，我们收集的免疫检测数据显示那些对IMA910中的两种或以上TUMAPs产生免疫应答的病人总体存活时间有明显的提高。鉴于这些阳性结果，我们目前正在评估最好的办法继续进一步发展这种新型的、令人兴奋的肿瘤治疗疫苗，它有可能成为结直肠肿瘤病人1线的治疗方案。”

在II期试验中，病人在接受第一次多肽疫苗IMA910治疗前注射一次环磷酰胺（CY）作为免疫调节剂。他们接受IMA910+GM-CSF治疗，用或不用附加的免疫调节剂咪喹莫特。病人将在9个月是时间内接受16次IMA910疫苗。这个试验在9个欧洲国家的51个中心进行。