PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer
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
研究概览
地位
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Jeong Il Yu
- 电话号码:+82234109598
- 邮箱:ro.yuji651@gmail.com
学习地点
-
-
Select Province/State
-
Seoul、Select Province/State、韩国、06351
- 招聘中
- Samsung Medical Center
-
接触:
- Jeong Il Yu
- 电话号码:0234109598
- 邮箱:ro.yuji651@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PULSAR-GC-1.2
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.