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临床试验/NCT06525714
NCT06525714尚未招募早期 1 期

Effect of Prophylactic Hyperthermic Intraperitonal Chemotherapy(HIPEC)After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer(cT3N+M0 and cT4aN+/-M0): A Randomized-controlled Study

The First Hospital of Jilin University0 个研究点目标入组 302 人开始时间: 2024年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
302
主要终点
3-year overall survival rate

研究概览

简要总结

The study focuses on patients with locally advanced gastric adenocarcinoma (cT3N+M0 and cT4aN+/-M0), assessing the feasibility, surgical safety, and oncological benefit of prophylactic HIPEC treatment following laparoscopic D2 radical surgery.

详细描述

Patients meeting the inclusion criteria will undergo laparoscopic D2 radical surgery. Before closing the abdomen during surgery, heat perfusion tubes are inserted, typically placing four tubes in a cross arrangement. Two drainage tubes at the pelvic floor exit through the upper abdomen, and two drainage tubes at the hepatorenal and splenorenal recesses exit through the lower abdomen, thus completing the tube placement.

Within 48 hours postoperative, the first infusion was performed with 3000-4000 ml of saline and 50 mg/m2 cisplatin at 43°C, with an infusion rate of 600 ml/min for a duration of 2 hours. During treatment, close attention is given to the patient's heart rate, blood pressure, oxygenation, and other vital signs. A total of 2 HIPEC treatments were conducted, each 48 hours apart. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: <1.25 m2, 40 mg; 1.25m2 ≤ body surface area ≤ 1.5m2, 50mg; body surface area >1.5m2, 60 mg bid) from day 1 to 14.

HIPEC is not performed postoperative. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: <1.25 m2, 40 mg; 1.25m2 ≤ body surface area ≤ 1.5m2, 50mg; body surface area >1.5m2, 60 mg bid) from day 1 to 14.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 and ≤70 years;
  • Male or nonpregnant female;
  • Gastric adenocarcinoma cT3N+M0 and cT4aN+/-M0 (according to the 8th edition of the AJCC TNM staging system);
  • No distant metastasis, suitable for D2 lymph node dissection;
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;
  • No prior cytotoxic chemotherapy, radiotherapy, or immunotherapy;
  • Written informed consent given before any study-related procedures;

排除标准

  • Other cancers within the past 5 years;
  • Distant metastasis (M1) found during surgery;
  • ASA (American Society of Anesthesiologists) classification ≥IV and/or ECOG performance status >2;
  • Severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases that make the patient unable to tolerate surgery;
  • A history of severe mental illness;
  • History of taking steroid medications;
  • Receiving other chemotherapy, radiotherapy, or immunotherapy;
  • Lack of written informed consent;

研究组 & 干预措施

Cisplatin, oxaliplatin, tegafur.

Experimental

Cisplatin, oxaliplatin, tegafur.

干预措施: cisplatin oxaliplatin tegafur (Drug)

结局指标

主要结局

3-year overall survival rate

时间窗: Three years after treatment

Three-year overall survival after treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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