NCT05002686Unknown2 期
Safety and Efficacy of Sintilimab in Combination With Albumin-Paclitaxel/Oxaliplatin/Capecitabine and Radiotherapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis: A Multiple Center Single Arm Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1 year Progression Free Survival (PFS)
研究概览
简要总结
Gastric cancer with retroperitoneal lymph node metastasis was considered as unresectable, to improve these patients' prognosis, we designed systematic conversion therapy including immunotherapy and chemoradiotherapy. The purpose of this study is to estimate safety and efficacy of Sintilimab in combination with chemoradiothrapy followed by D2 surgical resection in patients with advanced gastric cancer with retroperitoneal lymph node metastasis.
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
- •Pathology confirmed Gastric/Gastricgastroesophageal junction adenocarcinoma;
- •Radiolgical imging including CT,PET-CT or MRI diagnosed as retroperitoneal metastasis.
- •Did not receive previous systemic treatment (chemotheray, radiotherapy or both) for advanced disease before.
- •ECOG PS 0-
- •Adequate organ and bone marrow functions and life expectancy ≥12 weeks.
排除标准
- •Distant metastases except retroperitoneal metastasis (liver, lung, peitoneal metastasis...);
- •HER2-positive status;
- •Suspicious active bleeding or gastriointestineal obstruction phenomenon and Has difficulty in swallow tablets and food;
- •Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- •Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
- •Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
- •Known acute or chronic active hepatitis B infection (positive HBsAg and HBV DNA ≥ 200 IU/mL or ≥ 10^3 copies/mL positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection.
- •Women who are pregnant or nursing.
- •Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
- •Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years (subjects with vitiligo, psoriasis, alopecia or Grave's disease, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or type I diabetes mellitus only requiring insulin replacement, but not required systemic treatment in the last 2 years, are permitted to enroll) .
- •Known primary immunodeficiency.
- •Known active tuberculosis.
- •Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.
- •Known>=grade 3 allergy or hypersensitivity to Albumin-paclitaxel oxaliplatin, capecitabine or any monoclonal antibodies.
- •Human Immunodeficiency Virus (HIV) infection (HIV antibody positive).
- •Poorly controlled arterial hypertension (SBP ≥ 160mmHg or DBP ≥ 100 mmHg) with standard treatment .
- •Symptomatic congestive heart failure (New York Heart Association grade II-IV) or symptomatic, poorly controlled arrhythmia.
- •Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke and transient ischemic attack, within 6 months of enrollment.
- •Active or poorly controlled severe infection.
- •History of gastrointestinal perforation and /or fistula within 6 months before enrollment.
- •Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in this study.
研究组 & 干预措施
Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection
Experimental
干预措施: Sintilimab (Drug)
Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection
Experimental
干预措施: Albumin-Paclitaxel (Drug)
Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection
Experimental
干预措施: Capecitabine (Drug)
Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection
Experimental
干预措施: Oxaliplatin (Drug)
Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection
Experimental
干预措施: Radiation (Radiation)
Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection
Experimental
干预措施: Radical gastric cancer surgery (Procedure)
结局指标
主要结局
1 year Progression Free Survival (PFS)
时间窗: Approximately 3 years after the first participant is included
次要结局
- Number of participants experiencing clinical and laboratory adverse events (AEs)(Approximately 4 years after the first participant is included)
- R0 surgical resection percentage(Approximately 2 years after the first participant is included)
- Operative conversion percentage(Approximately 2 years after the first participant is included)
- Percentage of pathologic complete response(pCR)(Approximately 2 years after the first participant is included)
- Overall survival (OS)(Approximately 4 years after the first participant is included)
研究者
研究点 (1)
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