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FOLFIRI Plus Bevacizumab 5 mg/kg Versus 10 mg/kg as Second-line Therapy in Patients with Metastatic Colorectal Cancer Who Have Failed First-line Bevacizumab Plus Oxaliplatin-based Therapy: A Randomized Phase III Study (EAGLE Study)

机译：FOLFIRI加贝伐珠单抗5 mg / kg和10 mg / kg作为二线治疗转移性结直肠癌患者失败，但一线贝伐单抗加奥沙利铂为基础的治疗失败：III期随机研究（EAGLE研究）

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We planned a multicenter randomized phase III study to evaluate the efficacy of appropriate dose of bevacizumab (5 or 10 mg/kg) with FOLFIRI in patients with advanced/metastatic colorectal cancer who have failed prior bevacizumab plus oxaliplatin-based therapy. The primary endpoint is progression-free survival. The secondary endpoints are the toxicity, response rate, time to treatment failure, overall survival, overall survival from the start of the first-line treatment and second progression-free survival (time duration from the initiation of the first-line treatment until progression after the protocol treatment). A total of 370 patients were considered to be appropriate for this trial.

机译：我们计划进行一项多中心随机III期研究，以评估适当剂量的贝伐单抗（5或10 mg / kg）与FOLFIRI联合治疗在接受贝伐单抗加奥沙利铂为基础治疗的晚期/转移性结直肠癌患者中的疗效。主要终点是无进展生存期。次要终点是毒性，反应率，治疗失败的时间，总体生存率，从一线治疗开始到无进展的总生存期（从一线治疗开始到治疗后进展的持续时间）协议处理）。共有370名患者被认为适合该试验。

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作者
Mishima, Hideyuki; Oba, Koji; Sakamoto, Junichi; Muro, Kei; Yoshino, Takayuki; Hyodo, Ichinosuke; Maehara, Yoshihiko;
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年度 2011
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正文语种 {"code":"en","name":"English","id":9}
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1. CMAB009联合伊立替康或伊立替康单药二线治疗氟嘧啶和奥沙利铂治疗失败的KRAS野生型转移性结直肠癌患者的研究:一项前瞻性、开放、随机、Ⅲ期试验 [J] . 石远凯, 白丽, 张沂平, 癌症（英文版） . 2020,第007期
2. FOLFIRI plus bevacizumab 5 mg/kg versus 10 mg/kg as second-line therapy in patients with metastatic colorectal cancer who have failed first-line bevacizumab plus oxaliplatin-based therapy: A randomized phase III study (EAGLE study) [J] . Japanese journal of clinical oncology. . 2012,第2期

机译：FOLFIRI加贝伐单抗5 mg / kg与10 mg / kg作为二线治疗的转移性结直肠癌患者在一线贝伐单抗加奥沙利铂为基础治疗失败的患者：一项随机III期研究（EAGLE研究）
3. FOLFIRI Plus Bevacizumab 5 mg/kg Versus 10 mg/kg as Second-line Therapy in Patients with Metastatic Colorectal Cancer Whon Have Failed First-line Bevacizumab Plus Oxaliplatin-based Therapy: A Randomized Phase III Study (EAGLE Study) [J] . Yoshihiko Maehara Japanese Journal of Clinical Oncology . 2012,第2期

机译：FOLFIRI Plus贝伐单抗5 mg / kg和10 mg / kg作为转移性结直肠癌患者的二线治疗失败，这些患者一线贝伐单抗加奥沙利铂为基础的治疗均未通过：III期随机研究（EAGLE研究）
4. FOLFIRI plus bevacizumab as second-line therapy in patients with metastatic colorectal cancer after first-line bevacizumab plus oxaliplatin-based therapy: the randomized phase III EAGLE study [J] . Iwamoto S., Takahashi T., Tamagawa H., Annals of oncology: official journal of the European Society for Medical Oncology . 2015,第7期

机译：FOLFIRI加贝伐单抗作为转移性结直肠癌患者一线贝伐单抗联合以奥沙利铂为基础的治疗后的二线治疗：随机III期EAGLE研究
5. Correlation between development of hypertension and efficacy in metastatic colorectal cancer patients treated with bevacizumab [C] . Horinouchi Y., Sakurada T., Nakamura T., European Association for Clinical Pharmacology and Therapeutics . 2011

机译：北伐单抗治疗转移性结直肠癌患者高血压与疗效的相关性
6. A phase I study of vincristine, escalating doses of irinotecan, temozolomide and bevacizumab (VIT-B) in pediatric and adolescent patients with recurrent or refractory solid tumors of non-hematopoietic origin [D] . Venkatramani, Rajkumar. 2010

机译：长春新碱，伊非替康，替莫唑胺和贝伐单抗（VIT-B）逐步剂量在患有非造血源性复发或难治性实体瘤的儿童和青少年患者中的I期研究
7. FOLFIRI Plus Bevacizumab 5 mg/kg Versus 10 mg/kg as Second-line Therapy in Patients with Metastatic Colorectal Cancer Who Have Failed First-line Bevacizumab Plus Oxaliplatin-based Therapy: A Randomized Phase III Study (EAGLE Study) [O] . Hideyuki Mishima, Koji Oba, Junichi Sakamoto, -1

机译：FOLFIRI加贝伐珠单抗5 mg / kg和10 mg / kg作为二线治疗转移性结直肠癌患者失败但一线贝伐单抗加奥沙利铂为基础的治疗失败：III期随机研究（EAGLE研究）
8. Study protocol of the TRICOLORE trial: a randomized phase III study of oxaliplatin-based chemotherapy versus combination chemotherapy with S-1, irinotecan, and bevacizumab as first-line therapy for metastatic colorectal cancer [O] . 2015

机译：TRICOLORE试验的研究方案：以奥沙利铂为基础的化疗与联合用S-1，伊立替康和贝伐单抗联合化疗作为转移性结直肠癌一线治疗的III期随机研究

FOLFIRI Plus Bevacizumab 5 mg/kg Versus 10 mg/kg as Second-line Therapy in Patients with Metastatic Colorectal Cancer Who Have Failed First-line Bevacizumab Plus Oxaliplatin-based Therapy: A Randomized Phase III Study (EAGLE Study)

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