CompletedNot Applicable

Efficacy and Safety of Neoadjuvant Nivolumab Plus SOX Versus Nivolumab Plus FLOT in Patients With HER2-negative Gastric and Gastroesophageal Junction Adenocarcinoma

China120 participantsStarted 2021-01-01

Plain-language summary

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: * Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT regimen with nivolumab for the treatment of HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma. * Disease-free survival of preoperative adjuvant SOX plus nivolumab and FLOT plus nivolumab for HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma. 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. Histopathological confirmation of GC or GEJC. * 2\. Absence of prior anti-tumor treatments, encompassing surgical resection, chemotherapy, radiotherapy, or immunotherapy. * 3\. Age within the range of 18 to 75 years. * 4\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1. * 5\. Absence of concurrent malignancies. * 6\. For patients with resectable GC, those with locally advanced stage III and IVA were clearly included according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system, and there were no unresectable factors. * 7\. Patients with HER-2 negative. * 8\. Basal information such as hematology and pathological histology was complete. Exclusion Criteria: * 1\. Refusal of surgical resection subsequent to neoadjuvant therapy. * 2\. Receipt of other ICIs during the study period. * 3\. Receipt of corticosteroids during the study period. * 4\. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment. * 5\. Confirmed recurrence of GC. * 6\. Hypersensitivity to the study medication. * 7\. Systemic medical conditions contraindicating chemotherapy. * 8\. Psychiatric illnesses contraindicating chemotherapy. * 9\. Acute infections necessitating antibiotic therapy. * 10\. Uncontrolled diabetes mellitus. * 11\. Metastatic disease. * 12\. Severe malnutrition. * 13\. Active autoimmune disorders. * 14\. Pregn…

What they're measuring

adverse event

Timeframe: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days

Trial details

NCT IDNCT06440811

SponsorXijing Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-01