Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients
Trial Parameters
Brief Summary
This trial is An open-label, multicohort, multicenter clinical study aimed at evaluating the efficacy and safety of the cadonilimab combination regimen in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors
Eligibility Criteria
Inclusion Criteria: \- 1.Sign the informed consent form. 2. ≥18 years and ≤75 years . 3.Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (tumor center located within 5 cm proximally or distally from the esophagogastric junction according to the Siewert classification system). 4.Confirmed PD-L1 expression status (accepts PD-L1 expression test results confirmed by the investigator). 5.HER2 expression (accepts HER2 expression test results confirmed by the investigator): * Cohort 1 and Cohort 2: HER2-positive defined as IHC 3+, or IHC 2+ and ISH or FISH positive. ISH positivity is defined as a HER2 gene copy number to CEP17 copy number ratio ≥2.0; if the ratio is \<2.0 but the HER2 gene copy number \>6, it is also considered ISH positive. * Cohort 3: HER2 low expression, defined as IHC 1+ or IHC 2+ but ISH or FISH negative. 6.No prior systemic anti-tumor therapy. 7.With at least one measurable lesion (RECIST 1.1 criter