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

January 24, 2026 updated by: Bo Zhang, MD, Sichuan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gou Hongfeng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-75 years.
  2. Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  4. Clinically staged as T3-4a N+ M0 by computed tomography (CT) or magnetic resonance imaging (MRI).
  5. Considered eligible for curative resection.
  6. No prior antitumor therapy for the current disease.
  7. Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.
  8. Expected survival of ≥6 months.

Exclusion Criteria:

  1. Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.
  2. 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.
  3. 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.
  4. 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.
  5. Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SOX
oxaliplatin, S-1, four 3-week cycles were administered.
Drug: Oxaliplatin
Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.
Drug: S-1
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.
Experimental: ISOX
In the ISOX group, the regimen included ivonescimab, oxaliplatin, and S-1.
Drug: Oxaliplatin
Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.
Drug: S-1
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.
Drug: Ivonescimab (20mg/kg Q3W)
ivonescimab (20 mg/kg), four 3-week cycles were administered; ivonescimab was not administered in cycle 4. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
Through study completion,an average of 2 years
major pathologic response
Time Frame: Perioperative
defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy;
Perioperative
R0 resection
Time Frame: Perioperative
defined as microscopically margin-negative resection
Perioperative
overall survival (OS)
Time Frame: Through study completion,an average of 2 years
defined as the time from randomization to death from any cause;
Through study completion,an average of 2 years
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
Through study completion,an average of 2 years
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)
Through study completion,an average of 2 years
surgery-related complications
Time Frame: Through study completion,an average of 2 years
were graded according to the Clavien-Dindo classification;
Through study completion,an average of 2 years
An exploratory endpoint
Time Frame: Through study completion,an average of 2 years
was the evaluation of potential predictive biomarkers associated with treatment response
Through study completion,an average of 2 years
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)
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Investigators

  • Principal Investigator: Gou Hongfeng, Gastric Cancer Center, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu 610041, Sichuan, China.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Huaxi gastric cancer
  • Huaxi (Other Identifier: Huaxi)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) may not be shared due to privacy and confidentiality concerns, legal or ethical restrictions, limitations in data sharing agreements or consent, intellectual property rights, commercial interests, or because of technical and resource constraints related to data anonymization and sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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