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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
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To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sintilimab | Drug | Sintilimab 200mg, iv, 30-60min, q3w; |
| |
| nab-paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | disease control rate | up to three years |
| DOR | duration of response | up to three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiping Zhou, MD | Contact | 8687788145 | zhouap1825@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences | Recruiting | Beijing | 10000 | China |
The baseline characteristics of patients could be shared to othter researchers per request.
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| Drug |
Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w |
|
| AE | treatment related adverse event | from first dose to 90days of last dose |
| PFS | progression free survival | up to three years |
| OS | overall survival | up to three years |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C520255 | 130-nm albumin-bound paclitaxel |
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