Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
Location contact
Bin Xiong, Doctor
CONTACT
ChunWei Peng, Doctor
CONTACT
NCT Number: NCT06496919
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Wuhan, Hubei, 430000, China
Bin Xiong, Doctor
CONTACT
ChunWei Peng, Doctor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients who received rmhTNF intraperitoneal perfusion (intraperitoneal surgical field flushing perfusion or intraperitoneal thermal perfusion chemotherapy)
Time frame: after radical surgery for 1-3 years
Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma
Time frame: after radical surgery for 3 years
Survival without peritoneal implant metastasis after radical surgery for gastric and colorectal adenocarcinoma
Time frame: after radical surgery for 3 years
Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma
Time frame: 4 weeks after administration
Disease Control Ratel rate of malignant ascites in gastric and colorectal adenocarcinoma
Time frame: after radical surgery for 3 years
Time from the first study treatment until death from any cause
Time frame: after radical surgery for 3 years
Regional recurrence rate after radical surgery for gastric and colorectal adenocarcinoma (Local recurrence after radical surgery for gastric cancer refers to the recurrence of the duodenal stump, tumor bed, and residual stomach after anastomosis, Bi II style anastomosis, as well as the recurrence of regional lymph nodes)
Time frame: 24 hours after administration
The safety of rmhTNF intraperitoneal perfusion therapy
Contact information is provided by the study sponsor or research team.
Bin Xiong, Doctor
CONTACT
ChunWei Peng, Doctor
CONTACT
Wuhan University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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