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NOT YET RECRUITING
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

Sponsor: Wuhan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2024-08-01

Completion Date

2027-07-31

Last Updated

2024-07-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Recombinant Mutant Human Tumor Necrosis Factor

The patients who received rmhTNF intraperitoneal perfusion (intraperitoneal surgical field flushing perfusion or intraperitoneal thermal perfusion chemotherapy)

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China