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SOX regimen, consisting of oral S-1 and intravenous oxaliplatin, is the preferred regimen for perioperative chemotherapy for gastric cancer. The goal of this clinical trial is to compare the efficacy and safety between S-1 combined with oxaliplatin by arterial infusion, as neoadjuvant chemotherapy, and conventional SOX regimen, in locally advanced gastric cancer. The main question it aims to answer is: whether arterially infused oxaliplatin plus S-1 has the potential to be a better neoadjuvant option for patients with locally advanced gastric cancer.
Participants will be randomised, and receive:
Researchers will compare Major pathological response rate (MPR) ,pathologic complete response rate(pCR),the 2-year overall survival (OS) rates, 2-year disease free survival (DFS), R0 resection rates, and adverse events, to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arterial infusion group | Experimental |
|
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| SOX group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin by arterial infusion plus S-1 | Drug | 3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response rate | The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The proportion of patients with margin-free resection | 6 months |
| 2-year Disease Free Rate | The percentage of individuals in this study who are free of the signs and symptoms of gastric cancer at 2 years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenbin XU, Doctor | Contact | 86-15057315353 | shenbin_xu@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| SOX neoadjuvant | Drug | 3 cycles of SOX neoadjuvant chemotherapy every 21 days. |
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| Sintilimab neoadjuvant | Drug | 3 cycles of neoadjuvant immunotherapy every 21 days. |
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| gastrectomy plus D2 lymph node dissection | Procedure | All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection. |
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| SOX adjuvant, Sequential S-1 | Drug | 3 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups. Sequential S-1 chemotherapy every 21 days till 1 year postoperation. |
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| Sintilimab adjuvant | Drug | 3 cycles of adjuvant immunotherapy every 21 days. |
|
| 2 years |
| 2-year Overall Survival Rate | The percentage of individuals in this study who are alive two years after their diagnosis or the start of treatment. | 2 years |
| pathological Complete Response rate | The percentage of people with complete disappearance of all invasive carcinoma cells. | 6 months |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D005743 | Gastrectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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