Gastric AdenocarcinomaNCT07607119
PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer
A study testing PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy) and PULSAR in people with Gastric Adenocarcinoma and Stomach Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Stomach Neoplasms, Locally Advanced Gastric Cancer
- What is being tested?
- PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy) and PULSAR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Select Province/State, 06351
Jeong Il Yu, 0234109598, ro.yuji651@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Gastric Adenocarcinoma, Stomach Neoplasms, Locally Advanced Gastric Cancer, Unresectable Gastric Cancer
- Being tested
- PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy), PULSAR
- Keywords
- HER2-negative Stomach Cancer, Microsatellite Stable Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy)Radiation
Dose Schedule: 6 Gy per fraction administered every 3-4 weeks
PULSARRadiation
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 group | Role | What they receive |
|---|---|---|
| Experimental Group (PULSAR + Immunotherapy) | Experimental | 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) Receives: Radiation: PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy); Radiation: PULSAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: PFS at 12 months, calculated from the end date of the 1st PULSAR fraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 May 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Il Yu, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607119
- Sponsor's protocol ID
- PULSAR-GC-1.2
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07607119
- Acronym / sponsor ID
- PULSAR-GC-1.2
- Conditions
- Gastric Adenocarcinoma, Stomach Neoplasms, Locally Advanced Gastric Cancer, Unresectable Gastric Cancer
- Keywords
- HER2-negative Stomach Cancer, Microsatellite Stable Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (PULSAR + Immunotherapy) | Experimental | Radiation: PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy), Radiation: PULSARPatients 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy)Dose Schedule: 6 Gy per fraction administered every 3-4 weeks | Radiation | Experimental Group (PULSAR + Immunotherapy) |
| PULSARAdminister 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. | Radiation | Experimental Group (PULSAR + Immunotherapy) |
Primary outcome
Progression-Free Survival (PFS) Rate at 12 Months
Time frame: PFS at 12 months, calculated from the end date of the 1st PULSAR fraction.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy) and PULSAR in people with Gastric Adenocarcinoma and Stomach Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeong Il Yu (+82234109598, ro.yuji651@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.