OncoMatch/Clinical Trials/NCT06221748
DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy
Is NCT06221748 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Disitamab Vedotin and Cadonilimab for gastric cancer.
Treatment: Disitamab Vedotin · Cadonilimab · Paclitaxel — The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 1+, 2+, or 3+) (IHC 1+, 2+, or 3+)
Confirmation of HER2 (IHC 1+, 2+, or 3+)
Required: PD-L1 (CD274) expression
Confirmation of...PD-L1 expression
Disease stage
Metastatic disease required
Locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology and/or cytology
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard first-line therapy — advanced/metastatic
Subjects will only have failed or been intolerant to prior standard first-line therapy (excluding paclitaxel)
Cannot have received: antibody-drug conjugate (Disitamab Vedotin)
prior treatment with any antibody-drug conjugate including Disitamab Vedotin For Injection
Cannot have received: anti-PD-1/PD-L1 inhibitor (cadonilimab)
prior treatment with cardinolizumab
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL (no transfusion/erythropoietin within 2 weeks); ANC ≥ 1.5 × 10^9/L (no G-CSF within 2 weeks); Platelets ≥ 90 × 10^9/L (no platelet transfusion/thrombopoietin within 2 weeks)
Kidney function
Blood creatinine ≤ 1.5x ULN, or CrCl ≥ 60 mL/min
Liver function
Serum total bilirubin ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN (≤ 5x ULN with hepatic metastases)
Cardiac function
NYHA <3; LVEF ≥ 50%
Bone marrow function: Hemoglobin ≥ 9 g/dL... Platelet count ≥ 90 × 10^9/L... Liver function: Serum total bilirubin ≤ 1.5x ULN... ALT and AST ≤ 2.5x ULN (≤ 5x ULN with hepatic metastases)... Renal function: Blood creatinine ≤ 1.5x ULN, or CrCl ≥ 60 mL/min... Cardiac function: NYHA <3; LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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