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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Immune-related Adverse Event trials