A Multicenter Real-world Research on the Prevention and Treatment of Peritoneal Metastasis and Malignant Ascites by Intraperitoneal Infusion of rmhTNF in Gastric and Colorectal Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
Peritoneal metastasis is the main factor leading to poor prognosis in patients with gastric cancer or colorectal cancer. Although current systemic treatment regimens can prolong the time to peritoneal metastasis, the long-term survival rate is still poor. This is mainly due to the presence of the peritoneal plasma barrier, which limits the penetration of anti-tumor drugs and thus restricts the efficacy. In contrast, the use of intraperitoneal infusion chemotherapy allows anti-tumor drugs to directly reach the abdominal cavity, exposing metastatic nodules to high concentrations of drugs, and has a significant therapeutic effect on peritoneal metastases, resulting in better therapeutic effects Tumor necrosis factor (TNF) is a small molecule protein secreted by macrophages. There are two types of TNF - α: α and ß. TNF - α is produced by activated monocytes and macrophages, also known as cachectin. TNF - α is produced by activated lymphocytes, also known as lymphotoxins, and the two have similar activity. Previous studies have shown that rmhTNF is safe for intraoperative perfusion in gastrointestinal tumors.
In this real-world study, we will observe the safety and effectiveness of rmhTNF intraperitoneal perfusion in actual clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).
- •Patients with recurrent/metastatic gastric adenocarcinoma and colorectal cancer.
- •Age range from 18 to 80 years old;
- •Male or non pregnant or lactating female;
- •The bone marrow reserve function is good, and the blood routine meets the following conditions: white blood cell count ≥ 3.5 × 109/L, neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L;
- •The organ function is good, and the biochemical examination meets the following conditions: ALT ≤ 2.5 x Upper Limit of Normal (ULN), AST ≤ 2.5 x ULN, serum total bilirubin ≤ 1.5 x ULN, and blood creatinine ≤ 1.5 x ULN;
- •Functional status: 0-1 (ECOG);
- •preoperative ASA grading I-III;
- •Informed consent form has been signed for clinical treatment.
排除标准
- •Individuals who are allergic to TNF, biological products, or penicillin;
- •Those who do not meet the inclusion criteria during pregnancy or lactation;
- •Other situations where the researcher believes that patients are not suitable to participate in this trial.
研究组 & 干预措施
Gastric malignant tumor queue
干预措施: Recombinant Mutant Human Tumor Necrosis Factor (Drug)
Colorectal Malignant Tumor Queue
干预措施: Recombinant Mutant Human Tumor Necrosis Factor (Drug)
结局指标
主要结局
Event-Free Survival (EFS)
时间窗: after radical surgery for 1-3 years
Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma
Progression-Free Survival （PFS）
时间窗: after radical surgery for 3 years
Survival without peritoneal implant metastasis after radical surgery for gastric and colorectal adenocarcinoma
Objective Response Rate
时间窗: after radical surgery for 3 years
Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma
Disease Control Rate
时间窗: 4 weeks after administration
Disease Control Ratel rate of malignant ascites in gastric and colorectal adenocarcinoma
次要结局
- Adverse events(24 hours after administration)
- Overall Survival（OS）(after radical surgery for 3 years)
- Regional recurrence rate(after radical surgery for 3 years)
研究者
Bin Xiong, MD
Chief Physician
Wuhan University