Personalized ultrafractionated radiation plus immunotherapy for unresectable stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, phase II trial evaluating the safety and effectiveness of combining first-line systemic therapy plus immunotherapy with PULSAR, a personalized ultrafractionated stereotactic adaptive radiation approach. The goal is to improve local control, enable potential conversion to surgery, and extend progression-free survival while minimizing GI toxicity. Radiation is delivered in high-dose fractions with extended intervals and adaptive replanning to protect normal tissue. Eligible patients have HER2-negative, EBV-negative, MSS gastric cancer and have not progressed after at least three cycles of immunotherapy-containing regimens.

Why it matters

Who can join: the full rules

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.

Where it's running

• Samsung Medical Center
  Seoul, Select Province/State, South Korea Recruiting

Study contacts

• Study coordinator: Jeong Il Yu
• Email: ro.yuji651@gmail.com
• Phone: +82234109598

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.