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临床试验/NCT05593458
NCT05593458招募中3 期

A Multicenter, Randomized, Controlled Study of S-1 Combined With Oxaliplatin by Arterial Infusion Plus PD-1 Antibody Versus Conventional SOX Chemotherapy Plus PD-1 Antibody for Locally Advanced Gastric Cancer

Zhejiang University1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2023年3月1日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
190
试验地点
1
主要终点
Major Pathological Response rate
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

SOX regimen, consisting of oral S-1 and intravenous oxaliplatin, is the preferred regimen for perioperative chemotherapy for gastric cancer. The goal of this clinical trial is to compare the efficacy and safety between S-1 combined with oxaliplatin by arterial infusion, as neoadjuvant chemotherapy, and conventional SOX regimen, in locally advanced gastric cancer. The main question it aims to answer is: whether arterially infused oxaliplatin plus S-1 has the potential to be a better neoadjuvant option for patients with locally advanced gastric cancer.

Participants will be randomised, and receive:

  • 3 cycles of conventional SOX chemotherapy plus PD-1 antibody or arterial infused oxaliplatin plus S-1 and PD-1 antibody, as neoadjuvant chemotherapy;
  • Adequate gastric resection along with D2 lymph node dissection;
  • 3 cycles adjuvant chemotherapy using SOX regimen plus PD-1 antibody.
  • Administration of S-1 regularly till 1 year after surgery.

Researchers will compare Major pathological response rate (MPR) ，pathologic complete response rate（pCR）,the 2-year overall survival (OS) rates, 2-year disease free survival (DFS), R0 resection rates, and adverse events, to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • •Eastern Cooperative Oncology Group(ECOG) score 0-1
  • •Ambulatory males or females, aged 18-75 years
  • •Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III)
  • •Locally advanced gastric carcinoma (cT3N2-3M0, cT4aN1-3M0, cT4bNanyM0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition)
  • •Life expectancy more than 3 months
  • •Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • •Normal hepatic, renal, and bone marrow function (ALT/AST<2.5 fold of upper limit value;Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value; White Blood Cell count≥3 × 10^9/L, ANC ≥ 1.5 × 10^9/L,PLT≥ 80 × 10^9/L,Hb ≥ 90 g/L).

排除标准

  • •Patients can not bear surgical procedure.
  • •Pregnant or lactating women.
  • •HER2 overexpression(+++) confirmed by immunohistochemistry.
  • •Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.
  • •History of another malignancy within the last five years.
  • •History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
  • •Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
  • •History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation;
  • •Organ allografts requiring immunosuppressive therapy.
  • •Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
  • •Moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN).
  • •Hypersensitivity to any drug of the study regimen.
  • •With abdominal cavity implantation metastasis or distant metastasis.
  • •Unwilling or unable to comply with the protocol for the duration of the study.

研究组 & 干预措施

Arterial infusion group

Experimental
  1. 3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: SOX adjuvant, Sequential S-1 (Drug)

SOX group

Active Comparator
  1. 3 cycles of neoadjuvant chemotherapy: SOX regimen
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: SOX neoadjuvant (Drug)

Arterial infusion group

Experimental
  1. 3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: gastrectomy plus D2 lymph node dissection (Procedure)

SOX group

Active Comparator
  1. 3 cycles of neoadjuvant chemotherapy: SOX regimen
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: gastrectomy plus D2 lymph node dissection (Procedure)

SOX group

Active Comparator
  1. 3 cycles of neoadjuvant chemotherapy: SOX regimen
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: SOX adjuvant, Sequential S-1 (Drug)

Arterial infusion group

Experimental
  1. 3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: Sintilimab neoadjuvant (Drug)

Arterial infusion group

Experimental
  1. 3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: Sintilimab adjuvant (Drug)

SOX group

Active Comparator
  1. 3 cycles of neoadjuvant chemotherapy: SOX regimen
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: Sintilimab neoadjuvant (Drug)

Arterial infusion group

Experimental
  1. 3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: Oxaliplatin by arterial infusion plus S-1 (Drug)

SOX group

Active Comparator
  1. 3 cycles of neoadjuvant chemotherapy: SOX regimen
  2. 3 cycles of immunotherapy: sintilimab
  3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.
  4. S-1 administration till 1 year after surgery

干预措施: Sintilimab adjuvant (Drug)

结局指标

主要结局

Major Pathological Response rate

时间窗: 6 months

The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy.

次要结局

  • R0 resection rate(6 months)
  • 2-year Overall Survival Rate(2 years)
  • 2-year Disease Free Rate(2 years)
  • pathological Complete Response rate(6 months)

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian Chen

Head of Gastrointestinal Surgery, Second affiliated hospital of Zhejiang university School of Medicine

Zhejiang University

研究点 (1)

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