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This is an interventional clinical trial to assess the efficacy and safety of camrelizumab in combination with apatinib mesylate, paclitaxel-albumin and S-1 for translational treatment of gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+Apatinib+Paclitaxel-albumin+S-1 | Experimental | Camrelizumab:D1, 200 mg ivgtt Apatinib Mesylate:D1~21, 250 mg, po qd Paclitaxel-albumin:D1&D8, 100~120 mg/m2 S-1:D1~14, 60mg bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab+Apatinib+Paclitaxel-albumin+S-1 | Drug | Combination therapy of 4 drugs, 21 days for one cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | proportion of patients for whom radical resection can be achieved | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | 3 years |
| DFS | disease free survival (period) | 3 years |
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Inclusion Criteria:
age:18~70; expected survival>3 months
pathologically diagnosed gastric cancer or esophageal-gastric-junction cancer, being predominantly adenocarcinoma
no previous treatment of anti-cancer drugs
ECOG score 0~2
CT/MRI/PET-CT diagnosed as unresectable
no disfunction of major organs
lab results satisfy the following criteria:
7.women at child-bearing age must be tested negative within 7 days before inclusion, and must be willing to take contraception measures during treatment and within 12 weeks after last dose of treatment; men must be sterilized or willing to take contraception measures during treatment and within 12 weeks after last dose of treatment 8.willing to join this research with hand-signed written Informed consent 9.good compliance for follow-up
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongtao Zhang | Contact | 8618811792819 | 8618811792819 | zhongtao.z@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Deng | Beijing Friendship Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100050 | 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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| 3-year DFS | 3-year disease free survival (rate) | 3 years |
| PFS | progression free survival (period) | 3 years |
| OS | overall survival (period) | 3 years |
| 1-year OS | 1-year overall survival (rate) | 1 year |
| 3-year OS | 3-year overall survival (rate) | 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |