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This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab and Apatinib and S-1 and Oxaliplatin | Experimental |
| |
| Camrelizumab and S-1 and Oxaliplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab 200mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | Defined as the percentage of subjects with no residual tumor cells in the primary tumor (Becker Grade 1a) | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | |
| total Pathologic complete response (tpCR) | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhenggang Zhu | Ruijin Hospital | Principal Investigator |
| Yantao Tian | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital & Institute | Chengdu | China | ||||
| Changhai Hospital |
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| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Apatinib | Drug | Apatinib 250mg |
|
| S-1, Oxaliplatin | Drug | S-1, Oxaliplatin, q3w |
|
| R0 resection rate | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Pathologic Nodal Stage after Neoadjuvant Therapy | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Event free survival (EFS) | Up to approximately 3 years |
| Disease-free survival (DFS) | Up to approximately 3 years |
| Overall survival(OS) | Up to approximately 5 years |
| AEs | Up to approximately 18 months |
| Shanghai |
| China |
| Yantai Yuhuangding Hospital | Yantai | China |