A phase II trial of TAS-102 in combination with cetuximab for patients with RAS wild-type metastatic colorectal cancer refractory to previous anti-EGFR antibodies

未提供0 个研究点目标入组 55 人开始时间: 2017年9月7日最近更新: 2022年8月17日

试验速览

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•histopathologically confirmed unresectable or metastatic colorectal adenocarcinoma
•Wild-type RAS status
•Measurable disease by response evaluation criteria in solid tumors (RECIST version 1.1) criteria
•refractory disease or unable to tolerate agents (fluoropyrimidines, irinotecan, oxaliplatin) and antiangiogenic agent (bevacizumab,ramucirumab and aflibercept), and refractory to anti-EGFR antibodies (cetuximab and panitumumab)
•No prior TAS-102
•Patients who have not had major surgery (i.e., thoracotomy or laparotomy) within 4 weeks prior to enrollment.
•Patients who have not had radiotherapy for bone and/or brain metastases excluding primary colorectal cancer within 2 weeks prior to enrollment
•Patients who have not had any chemotherapy within 2 weeks prior to enrollment
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
•An estimated life expectancy of at least 12 weeks after enrollment
•Is able to take medications orally
•Patients must have the following adequate organ functions
•Ability to understand and the willingness to sign a written informed consent document

•Previous severe infusion reaction to Cmab
•Another malignancy with less than 5 disease-free years
•Presence of active local or systemic infection under treatment
•Positive for Hepatitis B surface antigen
•Radiographic evidence of severe pulmonary fibrosis or interstitial pneumonia on Computed Tomography
•Symptomatic brain and/or leptomeningeal metastases which needs treatment
•Serious complications
•Clinically significant mental or psychological disorder
•Patients requiring continuous treatment with systemic steroids
•Females who are pregnant, breastfeeding, or with a positive pregnancy test or males and females of reproductive potential unwilling to use adequate contraception
•Patients whose participation in the trial was judged to be inappropriate by the attending doctor

disease control rate

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发起方

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