Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or G
This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin
| Condition(s) | Resectable Gastric or Gastroesophageal Junction Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma. |
| Who can participate | Inclusion Criteria: * Be able and willing to provide written informed consent. * 18 to 75 years old. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ). * Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer \[AJCC\]) * Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Has adequate organ function. Exclusion Criteria: * Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage. * Is currently participating in a study of an investigational agent or using an investigational device. * Has undergone major surgery within 30 days of Study Day 1. * Has an active autoimmun |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Akeso |
| Locations | Tianjin, China |
| Start date | 2023-11-13 |
| NCT ID | NCT05960955 |
| Official listing | https://clinicaltrials.gov/study/NCT05960955 |