About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).
Disqualifiers
1. Individuals who are allergic to TNF, biological products, or penicillin; 2. Those who do not meet the inclusion criteria during pregnancy or lactation; 3. Other situations where the researcher believes that patients are not suitable to participate in this trial.
Trial population
The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).
Trial design
Cohort
Retrospective
Treatments tested in this trial
Recombinant Mutant Human Tumor Necrosis Factor
DrugThe patients who received rmhTNF intraperitoneal perfusion (intraperitoneal surgical field flushing perfusion or intraperitoneal thermal perfusion chemotherapy)
Treatment groups
Trial outcomes
Primary outcomes
Event-Free Survival (EFS)
Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma
Progression-Free Survival (PFS)
Survival without peritoneal implant metastasis after radical surgery for gastric and colorectal adenocarcinoma
Objective Response Rate
Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma
Disease Control Rate
Disease Control Ratel rate of malignant ascites in gastric and colorectal adenocarcinoma
Secondary outcomes
Overall Survival(OS)
Time from the first study treatment until death from any cause
Regional recurrence rate
Regional recurrence rate after radical surgery for gastric and colorectal adenocarcinoma (Local recurrence after radical surgery for gastric cancer refers to the recurrence of the duodenal stump, tumor bed, and residual stomach after anastomosis, Bi II style anastomosis, as well as the recurrence of regional lymph nodes)
Adverse events
The safety of rmhTNF intraperitoneal perfusion therapy
Sponsors and contacts
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