返回搜索
正在招募I 期 / II 期编号 NCT05319730

A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)

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

United States、Brazil、Chile、China、Germany、Italy、Japan、Norway、Singapore、South Korea、Switzerland、Taiwan

药品与企业信息

80-100 mg/m\^2 IV infusion, administered on days 1, 8, and 15 of every 28-day cycle.

180 mg/m\^2 IV infusion, administered on day 1 of every 14-day cycle.

Pembrolizumab生物制品

其他名称:MK-3475、KEYTRUDA®

200 mg IV infusion, administered every Q3W up to 35 infusions.

MK-4830生物制品

其他名称:anti-immunoglobulin-like transcript 4 (anti-ILT4)

800 mg IV infusion, administered Q3W up to 35 infusions.

其他名称:MK-7902、LENVIMA®

20 mg oral administration every day.

其他名称:SKB264、MK-2870、sac-TMT

4 mg/kg or 5 mg/kg IV infusion on Days 1, 15, and 29 of each 42-day cycle.

Administered per product label.

H2 Receptor Antagonist药物

Administered per product label.

研发企业

Merck Sharp & Dohme LLC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

Paclitaxel

Teva Pharmaceuticals, Inc.

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 Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.

适应症

Esophageal Squamous Cell Carcinoma

主动联系研究团队

总联系人(申办方/研究总部)

中国/港澳台研究中心

  • Anhui Provincial Hospital ( Site 3501)Hefei,Anhui,China
  • Beijing Cancer hospital-Digestive Oncology ( Site 3500)Beijing,Beijing Municipality,China
  • The First Affiliated Hospital of Xiamen University ( Site 3516)Xiamen,Fujian,China
  • The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)Xinxiang,Henan,China
  • Henan Cancer Hospital ( Site 3518)Zhengzhou,Henan,China
  • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)Huai'an,Jiangsu,China

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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: A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
ClinicalTrials.gov Identifier: NCT05319730
Sponsor: Merck Sharp & Dohme LLC
Investigational product: Paclitaxel, Irinotecan, Pembrolizumab, MK-4830, Lenvatinib

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:A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
试验编号:NCT05319730
申办方:Merck Sharp & Dohme LLC
研究药物:Paclitaxel、Irinotecan、Pembrolizumab、MK-4830、Lenvatinib

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)
用邮件客户端发送给 Trialsites@msd.com

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?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 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)。
在 ClinicalTrials.gov 查看官方页面