NCT06440811已完成1 期
Efficacy and Safety of Neoadjuvant Nivolumab Plus SOX Versus Nivolumab Plus FLOT in Patients With HER2-negative Gastric and Gastroesophageal Junction Adenocarcinoma: A Multicentre, Open-Label, Prospective Cohort Study
Xijing Hospital3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- adverse event
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological confirmation of GC or GEJC.
- •Absence of prior anti-tumor treatments, encompassing surgical resection, chemotherapy, radiotherapy, or immunotherapy.
- •Age within the range of 18 to 75 years.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-
- •Absence of concurrent malignancies.
- •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.
- •Patients with HER-2 negative.
- •Basal information such as hematology and pathological histology was complete.
排除标准
- •Refusal of surgical resection subsequent to neoadjuvant therapy.
- •Receipt of other ICIs during the study period.
- •Receipt of corticosteroids during the study period.
- •Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
- •Confirmed recurrence of GC.
- •Hypersensitivity to the study medication.
- •Systemic medical conditions contraindicating chemotherapy.
- •Psychiatric illnesses contraindicating chemotherapy.
- •Acute infections necessitating antibiotic therapy.
- •Uncontrolled diabetes mellitus.
- •Metastatic disease.
- •Severe malnutrition.
- •Active autoimmune disorders.
- •Pregnancy or lactation.
- •Positive serological test for hepatitis B or C virus infection,
- •Untreated central nervous system metastases peripheral neuropathy.
- •Severe myelosuppression.
- •Severe hepatic or renal insufficiency (Child-Pugh C, estimated glomerular filtration rate [eGFR] <30 mL/min).
- •Significant cardiac history.
- •Patients with a history of allogeneic organ transplantation.
- •History of malignancy within the past 5 years (with the exception of curative, localized cancer).
- •Patients with multiple factors affecting oral medication.
- •Vaccination within 4 weeks prior to the first dose of study drug.
- •Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
- •The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.
结局指标
主要结局
adverse event
时间窗: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
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
次要结局
- tumor regression grade(From the surgery to evaluation of tumor regression grade, assessed up to 1 week)
- disease-free survival(From date of diagnosis until the first documented recurrence or death, assessed up to 120 months)
- objective response rate(From the surgery to evaluation of objective response rate, assessed up to 1 week)
- 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.)
研究者
研究点 (3)
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