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正在招募II 期编号 NCT07863141

A Phase II Study of Anlotinib + PD-1 Inhibitor vs. PD-1 Inhibitor Maintenance After First-Line Chemoimmunotherapy in Advanced ESCC (Esophageal Squamous Cell Carcinoma)

报名条件（概要）

  • 年龄：18 Years – 75 Years
  • 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

anlotinib + PD-1 inhibitor药物

PD-1 inhibitor, 200 mg/240 mg, intravenous infusion, d1, Q3W; Anlotinib: 10 mg, qd, oral, d1-14, Q3W; Repeated every 3 weeks, for 2 years or until disease progression or intolerable toxicity

PD-1 inhibitor药物

PD-1 inhibitor, 200 mg/240 mg, intravenous infusion, d1, Q3W; Repeated every 3 weeks, for 2 years or until disease progression or intolerable toxicity

研发企业

Sun Yat-sen University研究机构/其他

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。

合作机构

  • Sun Yat-Sen University Cancer Center研究机构/其他
  • Jieyang People's Hospital研究机构/其他
  • Jiangmen Central Hospital研究机构/其他
  • Zhongshan People's Hospital, Guangdong, China研究机构/其他
  • Guangdong Second Provincial General Hospital研究机构/其他
  • Cancer Hospital of Guangdong Medical UniversityUNKNOWN

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）

Chemotherapy combined with PD-1 inhibitor immunotherapy is the standard treatment for advanced esophageal squamous cell carcinoma (ESCC), yet patient prognosis remains unsatisfactory, with a median PFS of only about 6 months and a 1-year PFS rate of only 25%. Adding anlotinib maintenance therapy on top of PD-1 inhibitor immunotherapy maintenance after chemoimmunotherapy may improve progression-free survival and overall survival. We plan to conduct a randomized, multicenter, open-label Phase II study of anlotinib combined with PD-1 inhibitor maintenance therapy versus PD-1 inhibitor monotherapy maintenance in advanced ESCC. A total of 112 patients with unresectable locally advanced, recurrent, or metastatic ESCC are planned to be enrolled. After enrollment, patients will receive either anlotinib combined with PD-1 inhibitor maintenance therapy or PD-1 inhibitor monotherapy maintenance, with a maximum treatment duration of 2 years. This study aims to evaluate the efficacy and safety of anlotinib combined with PD-1 inhibitor maintenance therapy in advanced ESCC by comparing it with the PD-1 inhibitor monotherapy maintenance group, further optimizing the comprehensive treatment model for esophageal cancer.

适应症

Esophageal Cancer (EC)

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

问自己是否符合条件、如何预筛

我的病情档案

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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 Phase II Study of Anlotinib + PD-1 Inhibitor vs. PD-1 Inhibitor Maintenance After First-Line Chemoimmunotherapy in Advanced ESCC (Esophageal Squamous Cell Carcinoma)
ClinicalTrials.gov Identifier: NCT07863141
Sponsor: Sun Yat-sen University
Investigational product: anlotinib + PD-1 inhibitor, PD-1 inhibitor

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 Phase II Study of Anlotinib + PD-1 Inhibitor vs. PD-1 Inhibitor Maintenance After First-Line Chemoimmunotherapy in Advanced ESCC (Esophageal Squamous Cell Carcinoma)
试验编号：NCT07863141
申办方：Sun Yat-sen University
研究药物：anlotinib + PD-1 inhibitor、PD-1 inhibitor

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 baoyong@mail.sysu.edu.cn

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