Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patient
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
| Condition(s) | Metastatic HER2 Positive Gastroesophageal Junction Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 consider |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Zhejiang Cancer Hospital |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2024-07-10 |
| NCT ID | NCT06650332 |
| Official listing | https://clinicaltrials.gov/study/NCT06650332 |