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To evaluate the efficacy and safety of chemoradiotherapy combined with tirelizumab in the treatment of initial unresectable locally advanced gastric cancer or gastroesophageal junction cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT with Tirelizumab | Experimental | Chemotherapy+Tirelizumab:PS regimen:S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily. Nab-PTX:preoperation:130mg/m2,d1,8,q3w;adjuvant:100mg/m2,d1,8,q3w; Tirelizumab:200mg d1 q3w. Concurrent Chemoradiotherapy: Radiation: 45-50Gy/25Fx;During radiation: Nab-PTX:100mg qw,Tirelizumab:200mg d1 q3w. Chemotherapy+Tirelizumab:PS regimen:S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily. Nab-PTX:preoperation:130mg/m2,d1,8,q3w; Tirelizumab:200mg d1 q3w. We will evaluate whether the tumor could be resectable through CT scan and Endoscope after two cycles of Chemotherapy+Tirelizumab and CRT.If it could be resctable,three cycles of adjuvant chemotherapy+Tirelizumab will be arranged;If not,another three cycles of chemotherapy+Tirelizumab will be arranged,then evaluate again. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-PTX,S-1,Tirelizumab | Drug | S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily. Nab-PTX:130mg/m2,d1,8,q3w;100mg qw(during radiation) Tirelizumab:200mg d1 q3w. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of resectable patients with negative incisal margin R0 resection rate | the rate of resectable patients with negative incisal margin | 18 weeks after treatment completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Lu ying, MD | Contact | 0571-88128142 | +86 | luyingliu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liu luying | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| Chemoradiation | Radiation | 45-50Gy/25F |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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