NCT05170503招募中2 期
Neoadjuvant Sintilimab Plus SOX in the Locally Advanced Esophagogastric Junction Adenocarcinoma: a Prospective, Single Arm Phase II Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2021年12月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (Tegafur+Oxaliplatin) for locally advanced esophagogastric junction adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aN0 or T1-4aN1-3M0
- •No previous anti-tumor treatment
- •ECOG PS: 0-1
- •The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period)：Absolute neutrophil count ≥ 1.5 × 109/L； Platelet ≥ 90 × 109/L； Hemoglobin ≥ 9g / dl; Serum albumin ≥ 3G / dl; Thyroid stimulating hormone (TSH) ≤ ULN (if abnormal, the levels of T3 and T4 should be investigated at the same time. If the levels of T3 and T4 are normal, they can be included in the group); Bilirubin ≤ ULN; ALT and AST ≤ 1.5 times ULN; AKP ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60ml / min.
- •Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the trial drug.
- •The patients voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.
排除标准
- •Known Her-2 positive
- •Any active autoimmune disease or history of autoimmunity (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism; Subjects with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; Asthma in which subjects need bronchodilators for medical intervention cannot be included).
- •Severe allergic reaction to monoclonal antibody.
- •The number of neutrophils in peripheral blood was less than 1500 / mm
- •There are cardiac clinical symptoms or diseases that are not well controlled.
- •Previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy.
- •The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive, HBVDNA > 2000IU/ml or copy number > 104/ml; Hepatitis C reference: HCV antibody positive.
- •According to the judgment of the researcher, the subject has other factors that may lead to the forced midway termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.
- •The researchers judged the patients with high risk of esophageal perforation or no potential possibility of surgery through endoscopic ultrasonography or imaging.
研究组 & 干预措施
Neoadjuvant chemo-immunotherapy
Experimental
Neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) Combined With Chemotherapy (Tegafur+Oxaliplatin) Each patient will complete 3 cycles of neoadjuvant therapy. After evaluating the radiographical response, operation with curative extent (Ivor-lewis or Mckeown procedure with two-field lymph node dissection) will be performed after 6 to 8 weeks from the last cycle of neoadjuvant treatment. Patients with and without surgery enter the survival follow-up period.
干预措施: Sintilimab (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: From date of enrollment until one month after resection
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
次要结局
- Overall survival(2-5 years)
- Disease-Free-Survival(2-5 years)
- R0 resection rate(From date of enrollment until one month after resection)
研究者
Yang Hong
Prof.
Sun Yat-sen University
研究点 (1)
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