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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a prospective, single-center, open, historically controlled real-world study.
The aims of this study is to evaluate the safety and effectiveness of Nab-paclitaxel combined with oxaliplatin and S-1 in the treatment of patients with advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Nab-paclitaxel combined with oxaliplatin and S-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel combined with oxaliplatin and S-1 | Drug | Nab-paclitaxel 100mg/m^2, D1, Q3W; oxaliplatin 85 mg/m^2, D1, Q3W; S-1 60 mg/m^2, D1-14, Q3W; Neoadjuvant chemotherapy 2 cycles, followed by surgery, continue to receive 6 cycles of adjuvant chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0 | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the rate of complete response (CR) or partial response (PR), as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. | 7-month |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Gastric adenocarcinoma diagnosed by histology.
Ambulatory cases, 18-75 years old
ECOG performance status ≤ 1
Have not received anti-tumor therapy previously (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
Patients able to tolerate abdominal surgery above grade 3
Has adequate organ function as defined by the following criteria:
No history of other tumors
Be willing and able to comply with the plan during the research period
Has given written informed consent
Life expectancy ≥ 6 months
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of the Air Force Medical University | Recruiting | Xi'an | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37201078 | Derived | Zheng J, Wang S, Xu G, Wang J, Wang Y, Luo J, Wang Y, Yang J. A small-scale, exploratory real-world study of nab-paclitaxel combined with oxaliplatin and tegafur in the perioperative treatment of advanced gastric cancer: a study protocol for a real-world clinical trial. J Gastrointest Oncol. 2023 Apr 29;14(2):1131-1140. doi: 10.21037/jgo-23-131. Epub 2023 Apr 27. |
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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 |
|---|---|
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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The proportion of all subjects who assessed the best overall curative effect as CR, PR, and disease stable (SD) according to the RECIST 1.1 standard.
| 7-month |
| Overall survival (OS) | It is defined as the time from the first doses durg to the time of death due to any reason. | 2-year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |