Gastric Cancer
Conditions
Keywords
rmhTNF, gastric cancer, colorectal cancer, peritoneal metastasis, intraperitoneal infusion chemotherapy
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.
Interventions
DRUGRecombinant Mutant Human Tumor Necrosis Factor
The patients who received rmhTNF intraperitoneal perfusion (intraperitoneal surgical field flushing perfusion or intraperitoneal thermal perfusion chemotherapy)
Sponsors
Wuhan University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage). 2\. Patients with recurrent/metastatic gastric adenocarcinoma and colorectal cancer. 3\. 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Countries
China
Contacts
Primary ContactChunWei Peng, Doctor
Backup ContactBin Xiong, Doctor
Outcome results
None listed