PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy), PULSAR.
- Who it may be relevant to
- Registry conditions: Gastric Adenocarcinoma, Stomach Neoplasms, Locally Advanced Gastric Cancer, Unresectable Gastric Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Radiation PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy)
Dose Schedule: 6 Gy per fraction administered every 3-4 weeks - Radiation PULSAR
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.
Primary outcome measures
- Progression-Free Survival (PFS) Rate at 12 Months [Time frame: PFS at 12 months, calculated from the end date of the 1st PULSAR fraction.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07607119 · PULSAR-GC-1.2