Comparative Study on the Efficacy of Mitomycin and Lobaplatin in the Treatment of Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 201
- 主要终点
- peritoneal metastasis
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 Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical 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 more than 20 years for CRS + HIPEC applying in treatment of patients with colorectal cancer peritoneal metastasis. While, to date, the kinds, doses, combinations of HIPEC drugs are not clearly been evaluate a criterion for local advanced colorectal cancer patients. Thus, This study aim to compare the efficacy of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with HIPEC. We plan to recruit 201 patients and divide into 3 groups, 2 drug groups and 1 control group, radomly. all patients with advanced co cancer receive radical surgery + HIPEC + mFOLFOX6/XELOX chemotherapy regimen. the mainly experimental variable is HIPEC drugs and three groups employ Mitomycin, Lobaplatin 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 colorectal 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 colorectal adenocarcinoma;
- •Clinical diagnosis of T3 stage or above without distant metastasis and can be given radical surgery (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 Mitomycin): 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: Mitomycin 30 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
干预措施: Mitomycin (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
peritoneal metastasis
时间窗: 3-year
peritoneal metastasis-free survival (pRFS)
overall survival
时间窗: 3-year
overall survival (OS)
次要结局
- Number of participants with immunosuppression events as assessed by blood immunological indicators(up to 4 weeks)
- The positive rate of cancer cells of participants by exfoliative cytology examination(1 week)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(up to 4 weeks)