OncoMatch/Clinical Trials/NCT06949033
Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Is NCT06949033 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Neoadjuvant cadonilimab combined with perioperative SOX for gastric cancer (including stomach and gastroesophageal junction [gej]).
Treatment: Neoadjuvant cadonilimab combined with perioperative SOX — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
pathologically confirmed diagnosis of HER-2 negative tumor
Excluded: HER2 (ERBB2) positive
Confirmed HER-2 positive tumor will be excluded
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy
Cannot have received: chemotherapy
Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy
Cannot have received: targeted therapy
Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy
Cannot have received: immunotherapy
Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy
Cannot have received: anti-PD-1 therapy
Subjects who have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.)
Cannot have received: anti-PD-L1 therapy
Subjects who have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.)
Cannot have received: anti-CTLA-4 therapy
Subjects who have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.)
Cannot have received: checkpoint inhibitor
Subjects who have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.)
Lab requirements
Blood counts
WBC ≥ 3.0 × 10^9/L; ANC ≥ 1.5 × 10^9/L; PLT ≥ 100 × 10^9/L; HGB ≥ 80 g/L
Kidney function
Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL/min for those with Cr > 1.5 × ULN
Liver function
Total bilirubin (TBIL) ≤ 1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN and ALT/AST levels ≤ 2.5 × ULN
Cardiac function
Cardiac function will be assessed using electrocardiogram and color Doppler ultrasound, and subjects must have had no myocardial infarction within the last six months. Hypertension and other coronary heart diseases must be controllable.
Blood Routine (no blood transfusion within 14 days): WBC ≥ 3.0 × 10^9/L; ANC ≥ 1.5 × 10^9/L; PLT ≥ 100 × 10^9/L; HGB ≥ 80 g/L. Hepatic Function: Total bilirubin (TBIL) ≤ 1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN and ALT/AST levels ≤ 2.5 × ULN. Renal Function: Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL/min for those with Cr > 1.5 × ULN. Coagulation Function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN. Cardiac Function: Cardiac function will be assessed using electrocardiogram and color Doppler ultrasound, and subjects must have had no myocardial infarction within the last six months. Hypertension and other coronary heart diseases must be controllable.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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