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

Wuhan University1 site in 1 country300 target enrollmentAugust 1, 2024

ConditionsGastric Cancer

InterventionsRecombinant Mutant Human Tumor Necrosis Factor

DrugsRecombinant Mutant Human Tumor Necrosis Factor

Overview

Phase: Not Applicable
Intervention: Recombinant Mutant Human Tumor Necrosis Factor
Conditions: Gastric Cancer
Sponsor: Wuhan University
Enrollment: 300
Locations: 1
Primary Endpoint: Event-Free Survival (EFS)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2024

End Date

July 31, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Wuhan University

Responsible Party

Principal Investigator

Bin Xiong, MD

Chief Physician

Wuhan University

Eligibility Criteria

Inclusion Criteria

•The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).
•Patients with recurrent/metastatic gastric adenocarcinoma and colorectal cancer.
•Age range from 18 to 80 years old;
•Male or non pregnant or lactating female;
•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;
•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;
•Functional status: 0-1 (ECOG);
•preoperative ASA grading I-III;
•Informed consent form has been signed for clinical treatment.

Exclusion Criteria

•Individuals who are allergic to TNF, biological products, or penicillin;
•Those who do not meet the inclusion criteria during pregnancy or lactation;
•Other situations where the researcher believes that patients are not suitable to participate in this trial.