Clinical trial · Interventional
PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
| Unresectable Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PULSAR | Radiation | — | UNRESOLVED |
| PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group (PULSAR + Immunotherapy)
- description
- 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)
- interventionNames
- Radiation: PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy)
- Radiation: PULSAR
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) Rate at 12 Months
- timeFrame
- PFS at 12 months, calculated from the end date of the 1st PULSAR fraction.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available