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PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer

2026年5月24日 更新者:Jeong Il Yu、Samsung Medical Center

A Prospective Phase II Study of Systemic Therapy With Immunotherapy Combined With Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) in Unresectable Locally Advanced Gastric Cancer

The purpose of this prospective, single-center, phase II study is to evaluate the clinical efficacy and safety of combining first-line systemic therapy plus immunotherapy with personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR) in patients with unresectable locally advanced gastric cancer.

研究概览

详细说明

Standard first-line treatment for unresectable locally advanced gastric cancer is systemic chemotherapy combined with immunotherapy, but the overall prognosis remains poor, and local complications like bleeding or obstruction frequently occur.

ULSAR delivers a high dose of radiation per fraction using a 3-to-4 week interval. This extended fraction interval allows normal tissue recovery and provides an opportunity for adaptive replanning before each fraction to minimize gastrointestinal toxicities while maximizing tumor dose delivery. Furthermore, this unique scheduling allows seamless integration with systemic immunotherapy without interrupting the regular chemotherapy cycle. This study specifically aims to evaluate if PULSAR can improve local control, conversion to surgery, and progression-free survival in HER-2 negative, EBV negative, and MSS gastric cancer patients whose tumors have not progressed after at least 3 cycles of first-line immunotherapy-containing systemic regimens.

研究类型

介入性

注册 (估计的)

53

阶段

  • 不适用

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

学习地点

    • Select Province/State
      • Seoul、Select Province/State、韩国、06351
        • 招聘中
        • Samsung Medical Center
        • 接触:

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:

Age 19 or more years. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. Histologically confirmed gastric adenocarcinoma. Tumor biomarker status: HER-2 negative, EBV negative, and Microsatellite Stable (MSS).

Unresectable, locally advanced extent at initial staging (Para-aortic lymph node [PALN] and Supraclavicular lymph node [SCN] metastases are allowed).

Has completed 3 or more cycles of first-line systemic therapy combined with immunotherapy without evidence of disease progression.

Presence of at least one evaluable lesion according to RECIST v1.1 that is deemed safely irradiable by the investigator.

Voluntary written informed consent provided by the subject.

Exclusion Criteria:

Pregnant or lactating women. Presence of brain metastases or leptomeningeal involvement. Prior history of radiation therapy to the intended target site. Severe uncontrolled comorbidities that, in the investigator's opinion, limit study participation or treatment compliance (e.g., uncontrolled infection, heart failure, arrhythmia, psychiatric illness).

Inability or unwillingness to comply with the study protocol procedures. Any condition deemed inappropriate for study participation by the principal investigator or attending physician.

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:Experimental Group (PULSAR + Immunotherapy)
Patients with unresectable locally advanced gastric cancer who did not progress after 3 or more cycles of first-line immunotherapy-containing systemic therapy will receive personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR)
Dose Schedule: 6 Gy per fraction administered every 3-4 weeks
Administer a single dose of 6 Gy of radiation, up to a total of 3 cycles, at 3-4 week intervals, along with standard systemic therapy.

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
Progression-Free Survival (PFS) Rate at 12 Months
大体时间:PFS at 12 months, calculated from the end date of the 1st PULSAR fraction.
Defined as the percentage of patients alive without any evidence of disease progression per RECIST v1.1 at 12 months, calculated from the end date of the 1st PULSAR fraction.
PFS at 12 months, calculated from the end date of the 1st PULSAR fraction.

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。

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 (实际的)

2026年5月15日

初级完成 (估计的)

2028年4月30日

研究完成 (估计的)

2030年4月30日

研究注册日期

首次提交

2026年5月19日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月24日

最后验证

2026年5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)?

不

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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