NCT06496919

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Recombinant Mutant Human Tumor Necrosis Factor	The patients who received rmhTNF intraperitoneal perfusion (intraperitoneal surgical field flushing perfusion or intraperitoneal thermal perfusion chemotherapy)

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2024-07-11
• Last updated: 2024-07-11

Locations

1 site across 1 country: China