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To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate and nab-paclitaxel .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab + Apatinib + nab-paclitaxel | Experimental | Camrelizumab combined with Apatinib mesylate tablets and nab-paclitaxel in the second-line treatment of advanced gastric cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab One course will last 21 days.Given once every 3 weeks at a dose of 200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate(DCR) | Disease Control Rate(DCR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST | one year |
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Inclusion Criteria:
Age: 18-70 years of age
Gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, sig-ring cell carcinoma sig, poorly differentiated adenocarcinoma por) confirmed by pathology (including histology or cytology) is an unresectable locally advanced or metastatic (stage IV) tumor.
For patients with advanced gastric cancer who had received standard first-line treatment in the past, the interval of the last chemotherapy should be more than 1 month .
Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.(CT scan of tumor lesion length≥10mm,CT scan short diameter≥15mm,scan slice thicknes 5mm).
ECOG(Eastern Cooperative Oncology Group):0-2 scores.
The expected survival time is more than 3 months.
The damage caused by subjects receiving other treatments has recovered, including receiving nitroso or mitomycin at intervals >=6 weeks; Received other cytotoxic drugs, radiotherapy or surgery >=4 weeks, and the wound had completely healed .
Patients with adequate organ function at the time of enrollment as defined below:
Blood routine examination standard (without blood transfusion within 14 days before enrollment):
Biochemical examination shall meet the following standards: a.BIL <1.25 ULN; b.ALT and AST< 2.5 ULN; If liver metastasis is present ALT and AST< 5 ULN; c.Serum creatinine Cr <=1 ULN; Serum creatinine >50ml/min (Cockcroft-Gault math);
Women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test.
Participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye feng, Doctor | Contact | 13860458889 | yefengdoctor@sina.com | |
| Li jia yi, Doctor | Contact | 13799792820 | ljy778848@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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| Apatinib Mesylate | Drug | Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday |
|
| nab-paclitaxel | Drug | nab-paclitaxel One course will last 21 days。Given twice every 3 weeks at a dose of 125 mg/m2 |
|
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| C520255 | 130-nm albumin-bound paclitaxel |
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