A 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
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT06496919
- Lead Sponsor
- Wuhan University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
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The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).
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Patients with recurrent/metastatic gastric adenocarcinoma and colorectal cancer.
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Age range from 18 to 80 years old; 4. Male or non pregnant or lactating female; 5. 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; 6. 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; 7. Functional status: 0-1 (ECOG); 8. preoperative ASA grading I-III; 9. Informed consent form has been signed for clinical treatment.
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- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Colorectal Malignant Tumor Queue Recombinant Mutant Human Tumor Necrosis Factor - Gastric malignant tumor queue Recombinant Mutant Human Tumor Necrosis Factor -
- Primary Outcome Measures
Name Time Method Event-Free Survival (EFS) after radical surgery for 1-3 years Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma
Progression-Free Survival （PFS） after radical surgery for 3 years Survival without peritoneal implant metastasis after radical surgery for gastric and colorectal adenocarcinoma
Objective Response Rate after radical surgery for 3 years Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma
Disease Control Rate 4 weeks after administration Disease Control Ratel rate of malignant ascites in gastric and colorectal adenocarcinoma
- Secondary Outcome Measures
Name Time Method Adverse events 24 hours after administration The safety of rmhTNF intraperitoneal perfusion therapy
Overall Survival（OS） after radical surgery for 3 years Time from the first study treatment until death from any cause
Regional recurrence rate after radical surgery for 3 years 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)
Trial Locations
- Locations (1)
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China