NCT07374250

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Gastric Cancer
• RCT

Interventions

Type	Name	Description
DRUG	Ivonescimab (20mg/kg Q3W)	ivonescimab (20 mg/kg), four 3-week cycles were administered; ivonescimab was not administered in cycle 4. .
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: China