Comparative Study on the Efficacy of Lobaplatin and Paclitaxel in the Treatment of Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with hyperthermic intraperitoneal chemotherapy
详细描述
Hyperthermic intraperitoneal chemotherapy (HIPEC) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (CRS). Further, there have been lots of randomized clinical trials assessing the efficacy of surgery + HIPEC for the treatment of locally advanced gastric cancer conducted. Nonetheless, to date, the kinds, doses, combinations of HIPEC drugs are not clearly been evaluate a criterion. Thus, This study aim to compare the efficacy of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with HIPEC. We plan to recruit 231 patients and divide into 3 groups, 2 drug groups and 1 control groups, radomly. all patients with advanced gastric cancer receive D2 surgery + HIPEC + SOX/XELOX chemotherapy regimen. the mainly experimental variable is HIPEC drugs and three groups employ Lobaplatin, Paclitaxel and none respectively. the endpoints of study include peritoneal metastasis, overall survival, immune status and perioperative safety assessment.
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
- Single (Participant)
盲法说明
the choice of HIPEC drugs is unknown to patients with advanced gastric cancer, but known to doctors, investigators and outcomes assessors.
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
- •No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;
- •Aged 18-75 years;
- •Male or non-pregnant or lactating women;
- •Pathological diagnosis of gastric adenocarcinoma;
- •Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2 radical resection (AJCC Version 8, 2018);
- •Normal function of major organs;
- •Routine blood examinations meeting the following criteria:
- •A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L;
- •Chemistry indexs meeting the following criteria:
- •A. TBIL < 1.5ULN; B. ALT and AST < 2.5ULN; ALB > 30 g/L C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula);
- •ECOG score 0-1;
排除标准
- •A history of other malignant tumors within 5 years;
- •Distant metastasis found during surgery;
- •Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;
- •Suffering from epilepsy or other mental illness, unable to control behavior;
- •Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;
- •Pregnant or lactating women.
- •Receiving anti-cancer drug therapy from other clinical trials.
研究组 & 干预措施
Drug group 1
hyperthermic intraperitoneal chemotherapy (HIPEC) (with paclitaxel): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation.
Choice of perfusate: Normal saline. Drug selection and dose: Paclitaxel 75 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
干预措施: Paclitaxel (Drug)
Drug group 2
hyperthermic intraperitoneal chemotherapy (HIPEC) (with lobaplatin): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation.
Choice of perfusate: Normal saline. Drug selection and dose: lobaplatin 50 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
干预措施: Lobaplatin (Drug)
结局指标
主要结局
overall survival
时间窗: 3-year
overall survival (OS)
peritoneal metastasis
时间窗: 3-year
peritoneal metastasis-free survival (pRFS)
次要结局
- The positive rate of cancer cells of participants by exfoliative cytology examination(1 week)
- Number of participants with immunosuppression events as assessed by blood immunological indicators(up to 4 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(up to 4 weeks)