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This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.
This trial is a Phase 3 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 for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cadonilimab+SOX | Experimental | Cadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) |
|
| Placebo+SOX | Placebo Comparator | Placebo plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab | Drug | Anti-PD-1/ CTLA-4 tetrameric bispecific antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | EFS is the time from date of randomization until the date of disease progression or death. | Up to 5 years |
| Pathological Complete Response (pathCR) Rate | PathCR rate is defined as the percentage of participants having a pathCR assessed by the investigators. PathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival is length of time from randomization until the date of death due to any cause. | Up to 10 years |
| Disease-free Survival (DFS) | DFS is defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifang Yao, MD | Contact | 86-0760-89873999 | clinicaltrials@akesobio.com | |
| Jiafu Ji, MD | Contact | jijiafu@hsc.pku.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100143 | China |
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| SOX chemotherapy |
| Drug |
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium |
|
| Placebo | Drug | Placebo |
|
| Up to 5 years |
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to 5 years |
| Fujian Provincial Cancer Hospital | Recruiting | Fuzhou | Fujian | China |
|
| Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
|
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | China |
|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Tianjin Provincial Tumor Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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