RecruitingPhase 3NCT06949033

Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Sponsor

Zuoyi Jiao

Enrollment

668 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy Adjuvant Chemotherapy Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])pCR Rate MPR ORR,OS,PFS

Summary

This study aims to investigate the efficacy and safety of neoadjuvant cadonilimab in combination with perioperative SOX chemotherapy, compared to perioperative SOX chemotherapy alone, in patients with diffuse or mixed-type locally advanced gastric or gastroesophageal junction adenocarcinoma. The main questions it seeks to answer are: 1. Is neoadjuvant cadonilimab plus SOX chemotherapy superior to neoadjuvant placebo plus SOX chemotherapy in terms of the pathological complete response (pCR) rate at the time of surgery? 2. To evaluate and compare the 3-year OS rate in patients receiving neoadjuvant cadonilimab plus SOX chemotherapy versus patients receiving placebo plus neoadjuvant SOX chemotherapy regimen. Participants will be divided into two groups: 1. Experimental group: Participants will receive intravenous cadonilimab (10 mg/kg) in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). 2. Control group: Participants will receive a placebo in combination with the SOX regimen. After completing 3-4 cycles of treatment, patients in both the experimental and control groups will undergo radical surgery with D2 or D2+ lymphadenectomy. Following surgery, patients will receive 4 cycles of adjuvant SOX chemotherapy at 70% of the standard dosage, administered every 21 days, starting within 3-6 weeks post-surgery.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment combining an immunotherapy drug (cadonilimab) with chemotherapy (oxaliplatin and S-1) given before surgery for people with a specific type of stomach or gastroesophageal junction cancer. The goal is to shrink the tumor before surgery and reduce the chance of cancer coming back. **You may be eligible if...** - You have been diagnosed with locally advanced stomach or gastroesophageal junction cancer that has not been treated yet - Your tumor is HER2-negative and falls into a specific cell pattern (diffuse or mixed type) - Your cancer is staged as T2, T3, or T4 with some lymph node involvement but no distant spread (M0) - You are between 18 and 75 years old and in adequate overall health **You may NOT be eligible if...** - You have received any prior treatment for this cancer - You have HER2-positive cancer - Your tumor has spread to distant organs - You have significant heart, liver, or kidney problems that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant cadonilimab combined with perioperative SOX

Cadonilimab: 10 mg/kg, iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA \< 1.25 m², 40 mg \* 2/day, 1.25 m² ≤ BSA \< 1.5 m², 50 mg \* 2/day, BSA ≥ 1.5 m², 60 mg \* 2/day)

DRUGNeoadjuvant placebo plus perioperative SOX

Placebo: iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA \< 1.25 m², 40 mg \* 2/day, 1.25 m² ≤ BSA \< 1.5 m², 50 mg \* 2/day, BSA ≥ 1.5 m², 60 mg \* 2/day)