PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer

Sponsor
Samsung Medical Center
Study ID
NCT07607119
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Locally Advanced Gastric Cancer
  • Stomach Neoplasms
  • Unresectable Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy) — RADIATION
    Dose Schedule: 6 Gy per fraction administered every 3-4 weeks
  • PULSAR — RADIATION
    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.

Study Details

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 Dates

First listed
May 26, 2026
Start date
May 15, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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)

Primary Outcome Measure

Progression-Free Survival (PFS) Rate at 12 Months [ Time Frame: PFS at 12 months, calculated from the end date of the 1st PULSAR fraction. ]

Central Contacts

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