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To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locally advanced gastric cancer | Experimental | Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Therapy | Procedure | Drug: Camrelizumab 200mg,d1,Repeat every 21 days for 3 courses; Oxaliplatin 130mg/m² ,d1;S-1 40-60mg,Bid, d1-14; S-1: bsa<1.25m2,40mg/time,twice a day;bsa1.25~1.5m2,50mg/time,twice a day;bsa≥1.5m2,60mg/次,twice a day,d1-d14; Procedure: Gastric cancer resection Distal gastrectomy combined with D2 lymph node dissection |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | defined as the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The sum of complete remission plus partial remission. | 30 days |
| PFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Di Guo | Contact | 0431-88782013 | guodi17790060921@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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|
Defined as the time from the start of randomization to the progression of the disease or the death of the patient.
| 3 years |
| OS | Defined as the time between the beginning of randomization and the death of the patient for any reason. | 3 years |
| postoperative complication | Defined as postoperative complications that occur within 30 days of surgery, they are classified according to the Clavien-Dindo classification system. | Up to 30 days post-operative |
| operative mortality | Defined as death of any cause within 30 days of surgery. | Up to 30 days post-operative |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |