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PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer

ConditionsGastric AdenocarcinomaStomach NeoplasmsLocally Advanced Gastric CancerUnresectable Gastric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

53 Participants
are divided into 1 treatment group
Group A: Experimental Group (PULSAR + Immunotherapy)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS) Rate at 12 Months

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.

Time frame
PFS at 12 months, calculated from the end date of the 1st PULSAR fraction.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov
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