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The goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT Regimen with nivolumab in HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma. The main question it aims to answer are:
Participants will be divided into two groups to use a FLOT chemotherapy regimen plus nivolumab (one group) and a SOX chemotherapy regimen plus nivolumab (another group). Researchers would compare tumor regression grade, adverse effects and survival benefit of two neoadjuvant regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLOT+nivolumab | Patients in the FLOT group received 4 cycles of standard FLOT chemotherapy, the FLOT chemotherapy cycle consists of: day 1: intravenous 5-FU 2600 mg/m² inserted through a peripherally inserted central catheter (PICC) for 24 hours intravenous folic acid 200 mg/m2 intravenous oxaliplatin 85 mg/m² intravenous docetaxel 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Nivolumab (360 mg) was administered intravenously (IV) over 30 minutes once every 3 weeks for 6 weeks (1 cycle, 2 doses). | ||
| SOX+nivolumab | Patients in the SOX group received 3 cycles of S-1 + OXA chemotherapy prior to radical gastrectomy.The SOX chemotherapy cycle consists of: day 1: intravenous OXA 130 mg/m² days 1-14: oral S-1 80 mg/m², 2 times/Day. Repeat next chemotherapy on day 22. Nivolumab (360 mg) was administered intravenously (IV) over 30 minutes once every 3 weeks for 6 weeks (1 cycle, 2 doses). |
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| Measure | Description | Time Frame |
|---|---|---|
| adverse event | adverse event caused by FLOT, SOX or nivolumab treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events | From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| tumor regression grade | Residual tumor components in post-radiotherapy samples and the proportion of fibrosis | From the surgery to evaluation of tumor regression grade, assessed up to 1 week |
| disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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The patients came from several tertiary hospitals in Xi'an city, Shaanxi Province, and were diagnosed with locally advanced gastric cancer, and the patients would accept either the neoadjuvant SOX+nivolumab or FLOT+nivolumab regimen.
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| Name | Affiliation | Role |
|---|---|---|
| Jipeng Li, Doctor | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu hospital | Xi'an | Shaanxi | 710032 | China | ||
| Shaanxi Provincial People's Hospital |
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Tumor tissues and adjacent tissues were obtained from every patient in these two cohorts. Thess tissues would be used for pathological histologyfor (Hematoxylin and eosin (H&E)) and cluadin18.2 identified by Immunohistochemistry (IHC) and tertiary lymphoid structures (TLS) identified by Immunofluorescence.
from diagnosis to recurrence or death
| From date of diagnosis until the first documented recurrence or death, assessed up to 120 months |
| objective response rate | objective response rate defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST). | From the surgery to evaluation of objective response rate, assessed up to 1 week |
| Duration of response | Duration of response | From the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause, assessed up to 120 months. |
| Xi'an |
| Shaanxi |
| China |
| Xijing hospital | Xi'an | Shaanxi | China |