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Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma:A Prospective Single-Arm, Phase II Study (NeoSCRTIC-01)

2026年9月8日 更新者:HONGYING_LIAO、Sixth Affiliated Hospital, Sun Yat-sen University
This prospective, single-arm phase II study will evaluate the efficacy and safety of lymphatic-drainage-sparing short-course radiotherapy combined with camrelizumab and nab-paclitaxel/carboplatin as neoadjuvant treatment for patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma. Participants will receive three 3-week cycles of camrelizumab plus chemotherapy, with 25 Gy in 5 fractions of short-course radiotherapy delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Definitive McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy. The primary endpoint is pathologic complete response (ypT0N0).

研究概览

详细说明

The study is designed as a Simon optimal two-stage, single-arm phase II trial. The target sample size is 33 participants, allowing for approximately 10% attrition. In stage 1, 15 participants will be enrolled; if at least 4 achieve pathologic complete response, enrollment will proceed to stage 2. A further 15 evaluable participants will then be enrolled. The protocol considers the regimen promising if at least 15 of 30 evaluable participants achieve pathologic complete response.

Eligible participants are treatment-naive adults aged 18-75 years with PET-CT and pathologically confirmed thoracic esophageal squamous cell carcinoma, clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (AJCC 9th edition), ECOG performance status 0-1, measurable disease by RECIST v1.1, and disease considered amenable to R0 resection.

Neoadjuvant treatment consists of camrelizumab 200 mg intravenously on Day 1 every 3 weeks plus nab-paclitaxel 260 mg/m² on Day 1 and carboplatin AUC 5 on Day 1 for three cycles. Short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle, targeting only the primary tumor and positive lymph nodes and sparing elective lymphatic drainage regions. Tumor imaging is performed after the second cycle and before surgery. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy when hematologic and organ function have recovered. Postoperative survival follow-up is planned every 3 months for 3 years.

研究类型

介入性

注册 (估计的)

33

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Hongying Liao MD, Professor / Chief Physician, MD and PhD
  • 电话号码:+86-020-35919121
  • 邮箱:liaohy2@mail.sysu.edu.cn

学习地点

    • Guangdong
      • Guanzhou、Guangdong、中国、510655
        • 招聘中
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • 接触:
          • Hongying Liao MD, Professor / Chief Physician, MD and PhD
          • 电话号码:+86-020-35919121
          • 邮箱:liaohy2@mail.sysu.edu.cn
        • 接触:
        • 首席研究员:
          • Hongying Liao, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Written informed consent before enrollment.
  • Age 18 to 75 years, any sex.
  • Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
  • Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
  • Disease assessed as amenable to R0 surgical resection before treatment.
  • At least one measurable lesion according to RECIST v1.1.
  • ECOG performance status 0-1.
  • Adequate organ function: absolute neutrophil count ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9 g/dL; serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min; bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; no blood components or hematopoietic growth factors within 14 days.
  • For women of childbearing potential: medically accepted contraception during treatment and for 3 months afterward; negative serum or urine HCG within 7 days before enrollment; not breastfeeding.
  • For men who are not surgically sterile: agreement to use medically accepted contraception with their partner during treatment and for 3 months afterward.
  • Willingness to participate and comply with safety and survival follow-up.

Exclusion Criteria:

  • Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
  • Previous or concurrent other malignancy.
  • Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
  • Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
  • Immunosuppressive agents for immunosuppression within 2 weeks before enrollment.
  • Symptomatic pleural or peritoneal effusion requiring therapeutic puncture or drainage.
  • Poorly controlled clinically significant cardiac disease as specified in the protocol.
  • Abnormal coagulation with bleeding tendency or thrombolytic/anticoagulant therapy.
  • Recent gastrointestinal conditions associated with bleeding or perforation risk.
  • Severe bleeding within 3 months, hemoptysis within 4 weeks, or thromboembolic event within 12 months according to protocol thresholds.
  • Active infection or unexplained fever >38.5°C during screening or before first dose.
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
  • History/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction.
  • Congenital/acquired immunodeficiency including HIV infection, or active hepatitis outside protocol-defined limits.
  • Participation in another clinical study or completion of a previous clinical study within 1 month; anticipated need for other systemic anticancer therapy.
  • Live vaccine within 4 weeks before study treatment or anticipated during the study.
  • Known history of psychotropic drug abuse, alcohol abuse, or illicit drug abuse.
  • Unable or unwilling to bear self-paid portions of study-related examinations or treatment.
  • Any other condition considered by the investigator to compromise participant safety, study completion, or data/sample collection.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin
Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.

Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.

Drug: Camrelizumab Camrelizumab 200 mg intravenously on Day 1 of each 3-week cycle for 3 cycles.

Drug: Nab-paclitaxel Nab-paclitaxel 260 mg/m² intravenously on Day 1 of each 3-week cycle for 3 cycles.

Drug: Carboplatin Carboplatin AUC 5 intravenously on Day 1 of each 3-week cycle for 3 cycles.

Radiation: Short-course radiotherapy 25 Gy in 5 fractions over 5 days, delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared.

Procedure: McKeown esophagectomy McKeown esophagectomy with thoracoabdominal two-field lymph node dissection, planned 4-6 weeks after completion of neoadjuvant therapy (maximum extension of 2 additional

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pathologic Complete Response (pCR) Rate
大体时间:At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Percentage of participants undergoing definitive surgery who have no residual viable tumor in the resected primary tumor and regional lymph nodes, defined in the protocol as ypT0N0.
At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.

次要结果测量

结果测量
措施说明
大体时间
Major Pathologic Response (MPR) Rate
大体时间:At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Major pathologic response (MPR) is defined as ≤10% residual viable tumor cells in the primary esophageal tumor resection specimen, regardless of lymph node status, as pre-specified in study protocol. The percentage of participants achieving this protocol-defined MPR criterion in post-neoadjuvant surgical resection specimen will be calculated.
At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Objective Response Rate (ORR)
大体时间:From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
Percentage of participants with complete response or partial response according to RECIST v1.1 based on protocol-specified imaging assessments.
From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
R0 Resection Rate
大体时间:Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
Percentage of participants undergoing esophagectomy with microscopically negative resection margins.
Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
Disease-Free Survival (DFS) Rate
大体时间:1 year and 3 years after surgery.
Disease-free survival rate at 1 and 3 years.
1 year and 3 years after surgery.
Overall Survival (OS) Rate
大体时间:1 year and 3 years after surgery.
Overall survival rate at the specified time points. Survival will be estimated using the Kaplan-Meier method.
1 year and 3 years after surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月10日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年8月28日

首先提交符合 QC 标准的

2026年9月8日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Individual participant data sharing is not currently planned. De-identified data may be considered upon reasonable request and subject to institutional and ethics requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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