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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

NCT06496919 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-07-11

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Wuhan University

    lead OTHER

Principal Investigators

  • Bin Xiong, Doctor · Zhongnan Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06496919 on ClinicalTrials.gov