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The goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fruquintinib+Sintilimab | Experimental | Fruquintinib: 5mg po, d1-d14, q3w Sintilimab: 200mg ivgtt, d1, q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib | Drug | Fruquintinib: 5mg po, d1-d14, q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The proportion of patients with complete response or partial response, using RECIST v 1.1. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator | 12 months |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuiping Tu | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | 200000 | China |
There is not a plan to make IPD available.
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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 |
|---|---|
| C000591844 | HMPL-013 |
| C000632826 | sintilimab |
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| Sintilimab |
| Drug |
Sintilimab: 200mg ivgtt, d1, q3w |
|
Time from randomization to death from any cause. |
| 12 months |
| Disease Control Rate (DCR) | The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1. | 12 months |
| Adverse Events | Adverse event assessed according to CTCAE v5.0. | 12 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |