OncoMatch/Clinical Trials/NCT07631000
A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer
Is NCT07631000 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Cadonilimab for gastric cancer.
Treatment: Cadonilimab — The purpose of this study is to find out whether adding cadonilimab to the usual chemotherapy approach is an effective and safe treatment for participants with locally advanced/resectable gastric cancer or gastroesophageal junction (GEJ) cancer
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
HER2-negative tumor (IHC 0, 1+, or IHC 2+ and FISH non-amplified)
Excluded: HER2 (ERBB2) overexpression
HER2-positive tumor (IHC 2+ and FISH-amplified, or IHC 3+)
Disease stage
Required: Stage T1 N+ M0, T2 N0-3 M0, T3 N0-3 M0, T4 N0-3 M0 (other)
T1 N+ M0 or T2-4 N0-3 M0 (per AJCC 8th edition) resectable disease deemed eligible for radical surgery
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anticancer therapy for the disease under study
Prior anticancer treatment for the disease under study (chemotherapy, radiation therapy, chemoradiation, approved or investigational therapy) prior to initiation of study treatment
Cannot have received: anti-PD-1 therapy
Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy
Cannot have received: anti-CTLA-4 therapy
Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; ANC ≥1.5 x 10^9/L; Platelet count ≥100 x 10^9/L
Kidney function
Measured creatinine clearance >50 mL/min (Cockcroft-Gault, actual body weight)
Liver function
Serum bilirubin ≤1.5 x ULN (≤3 x ULN for Gilbert's disease); ALT and AST ≤2.5 x ULN; albumin ≥2.8g/dL (albumin infusion not allowed within 14 days before treatment)
Adequate organ and marrow function as defined below: Hemoglobin ≥9.0 g/dL; ANC ≥1.5 x 10^9/L; Platelet count ≥100 x 10^9/L; Serum bilirubin ≤1.5 x ULN (≤3 x ULN for Gilbert's disease); ALT and AST ≤2.5 x ULN; Albumin ≥2.8g/dL (albumin infusion not allowed within 14 days before treatment); Measured creatinine clearance >50 mL/min (Cockcroft-Gault, actual body weight)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07631000 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Are patients with ERBB2 alterations eligible?
No. ERBB2 overexpression is an exclusion criterion.
What disease stage is eligible?
Stage T1 N+ M0 or T2 N0-3 M0 or T3 N0-3 M0 or T4 N0-3 M0 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages