A Phase III, randomized, two armed, parallel, double blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Cetuximab (produced by CinnaGen) and FOLFIRI compared with Erbitux® (Cetuximab, the reference drug, produced by Merck Company) and FOLFIRI as first-line treatment for RAS wild-type Metastatic Colorectal Cancer

CinnaGen company0 个研究点目标入组 234 人开始时间: 待定最近更新: 2024年3月6日

适应症

试验速览

暂无简介。

•male or female
•Age of 18 till 75
•histologically confirmed adenocarcinoma of the colon or rectum
•having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
•metastatic disease that could not be resected for curative purposes
•immunohistochemical evidence of tumor EGFR expression (expanded wild-type RAS)
•Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
•life expectancy of longer than 3 months (by clinical assessment)
•adequate organ and marrow function.

•Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy
•the use of radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational drug in the 30-day period before the start of treatment in our trial
•female patients who are pregnant or lactating
•patients with a history of another primary malignancy in less than 5 years, with the exception of non-melanoma skin cancer and carcinoma in-situ of uterine cervix
•patients with history of allergic reactions attributed to compounds chemically or biologically similar to Cetuximab, irinotecan, 5-FU or leucovorin
•adjuvant treatment that was terminated 6 months or less before the start of treatment in our trial
•inability to comply with study and/or follow-up procedures
•Subjects with known infection with HIV, HBV, HCV
•first line treatment in patient with right sided primary tumor

发起方