PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer
Recruiting now · Not applicable
Conditions studied: Gastric Adenocarcinoma, Stomach Neoplasms, Locally Advanced Gastric Cancer, Unresectable Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT07607119
- Run by
- Samsung Medical Center
- People needed
- 53
- Starts
- 2026-05-15
- Expected to finish
- 2030-04-30
- Last updated by the study team
- 2026-05-28
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Samsung Medical Center — Seoul, Select Province/State, South Korea (enrolling)
Full record on ClinicalTrials.gov
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