Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496919
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
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
Organization:
Wuhan University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
In this real-world study we will observe the safety and effectiveness of rmhTNF intraperitoneal perfusion in actual clinical settings
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None