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正在招募II 期编号 NCT07016126

D-BACE in Combination With Chemotherapy and Camrelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC

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

D-BACE in combination with chemotherapy and karelizumab组合产品

D-BACE (drug-eluting bead bronchial arterial chemoembolization) using the watershed vascular embolization concept: 3 cycles of D-BACE with 300-500 μm DC Bead microspheres loaded with epirubicin 50 mg, administered via superselective transarterial chemoembolization of the tumor-feeding watershed vessels. The procedure emphasizes layered and zonal embolization of core and peripheral watershed arteries under digital subtraction angiography (DSA) guidance, with dynamic endpoint assessment using the "near-stasis" criterion. D-BACE is followed within 7 days by camrelizumab (a PD-1 inhibitor) and platinum-based doublet chemotherapy (e.g., pemetrexed plus carboplatin for non-squamous NSCLC, or albumin-bound paclitaxel plus carboplatin), with the specific regimen determined by the investigator. This neoadjuvant combination is evaluated in a Simon two-stage design with major pathological response (MPR) as the primary endpoint.

研发企业

Guangdong Provincial People's Hospital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。

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 study is a single-arm prospective single-center phase II study. Subjects are untreated resectable stage II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC. Forty-six subjects will be enrolled in this prospective observation, using a Simon two-stage optimal design, aimed at evaluating the clinical efficacy and safety of D-BACE in combination with neoadjuvant chemotherapy and camrelizumab in patients with resectable stage II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC. The primary endpoint is the major pathological response (MPR) rate, defined as no more than 10% residual viable tumor cells in the primary tumor bed upon comprehensive pathological assessment. The treatment group regimen will be 3 cycles of D-BACE (DCB drug-eluting microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and camrelizumab (the specific regimen of chemotherapy will be determined by the investigator, and platinum-based doublet chemotherapy will generally be used). Adverse events will be monitored throughout the trial and graded for severity according to NCI CTCAE version 5.0. Tissue and blood specimens will be dynamically collected during the course of treatment for translational research.

适应症

NSCLC (Non-small Cell Lung Cancer)

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总联系人（申办方／研究总部）

问自己是否符合条件、如何预筛

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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: D-BACE in Combination With Chemotherapy and Camrelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC
ClinicalTrials.gov Identifier: NCT07016126
Sponsor: Guangdong Provincial People's Hospital
Investigational product: D-BACE in combination with chemotherapy and karelizumab

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：D-BACE in Combination With Chemotherapy and Camrelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC
试验编号：NCT07016126
申办方：Guangdong Provincial People's Hospital
研究药物：D-BACE in combination with chemotherapy and karelizumab

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 cuiwei@gdph.org.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