Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.
报名条件（概要）
- 年龄：18 Years – 不限
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
Enlituo®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. FOLFOX Regimen: Oxaliplatin: 85 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. Leucovorin (LV): 400 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. 5-Fluorouracil (5-FU): Bolus: 400 mg/m², administered via intravenous bolus, on Day 1 of each treatment cycle. Continuous Infusion: 1200 mg/(m²•day) for 2 days (total dose 2400 mg/m²), administered via continuous intravenous infusion over 46 to 48 hours, on Days 1 to 3 of each treatment cycle. One treatment cycle spans 2 weeks.
Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. Erbitux® will be administered for up to 16 weeks. Participants who continue to derive benefit (including SD, PR, and CR) after 16 weeks will crossover to receive Enlituo® combined with FOLFOX. FOLFOX Regimen: Oxaliplatin: 85 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. Leucovorin (LV): 400 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. 5-Fluorouracil (5-FU): Bolus: 400 mg/m², administered via intravenous bolus, on Day 1 of each treatment cycle. Continuous Infusion: 1200 mg/(m²•day) for 2 days (total dose 2400 mg/m²), administered via continuous intravenous infusion over 46 to 48 hours, on Days 1 to 3 of each treatment cycle. One treatment cycle spans 2 weeks.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS/BRAF wild-type and MSS/pMMR locally advanced/metastatic colorectal cancer. Enrolled participants will be stratified according to ECOG performance status (0 vs. 1) and primary tumor location (left-sided or right-sided colon) and randomly assigned in a 1:1 ratio to either the experimental group (Enlituo® + FOLFOX) or the control group (Erbitux® + FOLFOX). Participants will: * Receive Enlituo®/Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. * Receive FOLFOX * Participants in the Erbitux® plus FOLFOX group who achieve CR, PR, or SD at 16 weeks will cross over to receive Enlituo® plus FOLFOX. * Be recommended to undergo efficacy assessments every 8 weeks (±7 days). * Comply with the blood sample collection procedures for pharmacokinetic (PK) and immunogenicity analyses. * Be required to provide baseline tumor biopsy specimens or 8-10 unstained slides of archived tumor tissue (formalin-fixed, paraffin-embedded) from within the past 3 years. The Blinded Independent Central Review (BIRC) will assess: * Objective Response Rate (ORR) within 16 weeks. * Disease Control Rate (DCR) within 16 weeks. * Duration of Response (DoR). * Progression-Free Survival (PFS). The investigators will assess: * ORR within 16 weeks. * DCR within 16 weeks. * DoR. * PFS. * Overall Survival (OS). * Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as findings from laboratory tests, vital signs, and physical examinations. * Dose intensity, and incidence of dose interruptions, dose reductions, and treatment discontinuations due to AEs.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Jiang Guoguojiang@zaiming.com+86(25)85566666
中国／港澳台研究中心
- Sun Yat-Sen University Cancer CenterGuangzhou，China
问自己是否符合条件、如何预筛
我的病情档案
档案只保存在您自己的浏览器里，不会上传，任何人（包括本站）都看不到。
英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status. ClinicalTrials.gov Identifier: NCT07595276 Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd Investigational product: Enlituo®, Erbitux® About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status. 试验编号：NCT07595276 申办方：Taizhou Mabtech Pharmaceutical Co.,Ltd 研究药物：Enlituo®、Erbitux® 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。