Not provided
Not provided
Not provided
Not provided
Not provided
difficult in enrolling participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| camrelizumab+chemotherapy | Experimental | neoadjuvant treatment with camrelizumab+chemotherapy |
|
| chemotherapy | Active Comparator | neoadjuvant treatment with chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab+chemotherapy | Drug | camrelizumab 200mg,ivdrip,q3w; albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip,d1,q3w; oxaliplatine 85mg/m2、ivdrip,d1,q3w; S-1 40 mg/m2,po, bid,d1~d14,q3w. 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| major pathologic response rate | complete or subtotal regression (<10% residual tumor per tumor bed) | one month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| complete pathologic response rate | complete regression (no residual tumor per tumor bed) | one month after surgery |
| R0 resection rate | surgically removed tissue without residual cancer cells |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chemotherapy | Drug | albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip,d1,q3w; oxaliplatine 85mg/m2、ivdrip,d1,q3w; S-1 40 mg/m2,po, bid,d1~d14,q3w. 3 cycles. |
|
| one month after surgery |
| Overall survival | the time from the start of randomization to death due to any cause. | 3 years |
| Disease-free survival | the time from the start of randomization to the incurable resection, local recurrence or metastasis, or death from any cause. | 3 years |
| perioperative complications | perioperative complications | the time from the start of randomization to 3 months after surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |