Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University
About this trial
The purpose of this clinical trial is to evaluate whether perioperative ivonescimab in combination with S-1 and oxaliplatin (SOX) is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.
Primary Objective:
To determine whether perioperative ivonescimab plus SOX improves the pathological complete response (pCR) rate compared with SOX alone in patients with locally advanced gastric or GEJ adenocarcinoma.
Study Design:
Participants will be randomly assigned to receive either ivonescimab plus SOX or SOX alone to evaluate the potential added benefit of ivonescimab in this setting.
Participation Details:
Participants will receive the assigned treatment (ivonescimab plus SOX or SOX alone) every 21 days for approximately 4 months.
They will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.
Participants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.
Eligibility criteria
Qualifiers
Age 18-75 years.
Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Clinically staged as T3-4a N+ M0 by computed tomography (CT) or magnetic resonance imaging (MRI).
Disqualifiers
Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.
Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.
Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.
History of thromboembolic or arterial/venous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
Trial design
Treatments tested in this trial
- Ivonescimab (20mg/kg Q3W)
- Oxaliplatin
- S-1
Treatment groups
154 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov