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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 or more years. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •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.
排除标准
- •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.
研究者
Jeong Il Yu
Associate Professor
Samsung Medical Center