A Phase 2 interventional study of Ivonescimab (20mg/kg Q3W) and Oxaliplatin in Gastric Cancer and RCT, sponsored by Sichuan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Sichuan University · Phase 2, Interventional, and Treatment
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.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 154 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
oxaliplatin, S-1, four 3-week cycles were administered.
Drug: Oxaliplatin · Drug: S-1
In the ISOX group, the regimen included ivonescimab, oxaliplatin, and S-1.
Drug: Ivonescimab (20mg/kg Q3W) · Drug: Oxaliplatin · Drug: S-1
ivonescimab (20 mg/kg), four 3-week cycles were administered; ivonescimab was not administered in cycle 4. .
Oxaliplatin (130 mg/m², administered intravenously on day 1), four 3-week cycles were administered.
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.
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
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
major pathologic response
defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy;
Time frame: Perioperative
R0 resection
defined as microscopically margin-negative resection
Time frame: Perioperative
overall survival (OS)
defined as the time from randomization to death from any cause;
Time frame: Through study completion,an average of 2 years
disease-free survival (DFS)
defined as the time from the post-surgery baseline scan to the first occurrence of relapse, metastasis, or death from any cause
Time frame: Through study completion,an average of 2 years
safety
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)
Time frame: Through study completion,an average of 2 years
surgery-related complications
were graded according to the Clavien-Dindo classification;
Time frame: Through study completion,an average of 2 years
An exploratory endpoint
was the evaluation of potential predictive biomarkers associated with treatment response
Time frame: Through study completion,an average of 2 years
Quality of life
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)
Time frame: Perioperative
Plan to share: No — 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.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sichuan University