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NCT Number: NCT07374250

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site RCT Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

To evaluate the efficacy and safety of ivonescimab in combination with S-1 and oxaliplatin (SOX) for the treatment of locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in the neoadjuvant (perioperative) setting, with the goal of improving the pathological complete response (pCR) rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Considered eligible for curative resection.
  • No prior antitumor therapy for the current disease.
  • Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.
  • Expected survival of ≥6 months.

Exclusion criteria

  • 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.
  • Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.

Treatment and study plan

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.

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)

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

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

  2. major pathologic response

    Time frame: Perioperative

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

  3. R0 resection

    Time frame: Perioperative

    defined as microscopically margin-negative resection

  4. overall survival (OS)

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

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

  5. disease-free survival (DFS)

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

    defined as the time from the post-surgery baseline scan to the first occurrence of relapse, metastasis, or death from any cause

  6. safety

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

    Treatment-related adverse events (TRAEs) with potential immunologic etiology were categorized and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) (Version 5.0)

  7. surgery-related complications

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

    were graded according to the Clavien-Dindo classification;

  8. An exploratory endpoint

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

    was the evaluation of potential predictive biomarkers associated with treatment response

  9. Quality of life

    Time frame: Perioperative

    Quality of life was assessed using the EORTC QLQ-STO22 and EORTC QLQ-C30 questionnaires, administered at three time points: within one week before initiation of neoadjuvant therapy, within one week before the fourth neoadjuvant therapy cycle, and at 30 days postoperatively (±3 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Gou Hongfeng

CONTACT

[email protected]

+86-18980602292

Hu Qiancheng, MD

CONTACT

[email protected]

+86-17780026135

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) Versus SOX Alone for Locally Advanced Gastric or GEJ Adenocarcinoma: A Multicenter Randomized Phase II Study

Acronym: Huaxi

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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