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To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab combined with apatinib and oxaliplatin plus S1 | Experimental |
| |
| oxaliplatin plus S1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 4 cycles. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response | Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell | 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response | Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell | 4 weeks after surgery |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chen lu chuan, bachelor | Contact | 13905022862 | 86 | Luchuanchen@sina.cn |
| Ye Z sheng, Doctor of Medicine | Contact | 13950203076 | 86 | flyingengel@sina.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian cancer hospital | Recruiting | Fuzhou | Fujian | 350500 | China |
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| apatinib | Drug | Participants will receive apatinib, 250mg, qd,every 3 weeks for 3 weeks |
|
| oxaliplatin | Drug | Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks. |
|
| S-1 | Drug | Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks. |
|
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
| At the end of Cycle 3 (each cycle is 21 days)] |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| C553458 | apatinib |
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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