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Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma

ConditionsGastric CancerRCT
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ivonescimab (20mg/kg Q3W)

    Drug

    ivonescimab (20 mg/kg), four 3-week cycles were administered; ivonescimab was not administered in cycle 4. .

  • Oxaliplatin

    Drug

    Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.

  • S-1

    Drug

    S-1 (administered orally twice daily on days 1-14 of each 21-day cycle, with the daily dose determined by body surface area: \<1.25 m², 80 mg/day; ≥1.25 to \<1.5 m², 100 mg/day; ≥1.5 m², 120 mg/day), four 3-week cycles were administered.

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: SOXActive comparator 2 interventions
Group B: ISOXExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Total pathological complete response (pCR; ypT0) assessed by investigators, defined as the complete absence of tumor cells in the primary tumor on pathological examination.

Time frame
Perioperative

Secondary outcomes

1

Event-free survival (EFS)

Event-free survival (EFS), defined as the time from randomization to the first occurrence of relapse, metastasis, or death from any cause;

Time frame
Through study completion,an average of 2 years
2

major pathologic response

defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy;

Time frame
Perioperative
3

R0 resection

defined as microscopically margin-negative resection

Time frame
Perioperative
4

overall survival (OS)

defined as the time from randomization to death from any cause;

Time frame
Through study completion,an average of 2 years

Other outcomes

Sponsors and contacts

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

Sichuan University

Lead sponsor

Source ClinicalTrials.gov

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