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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Gastric malignant tumor queue

Recombinant Mutant Human Tumor Necrosis Factor

Intervention Type DRUG

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

Colorectal Malignant Tumor Queue

Recombinant Mutant Human Tumor Necrosis Factor

Intervention Type DRUG

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

Interventions

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Recombinant Mutant Human Tumor Necrosis Factor

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).

2\. Patients with recurrent/metastatic gastric adenocarcinoma and colorectal cancer.

3\. Age range from 18 to 80 years old; 4. Male or non pregnant or lactating female; 5. 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; 6. 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; 7. Functional status: 0-1 (ECOG); 8. preoperative ASA grading I-III; 9. Informed consent form has been signed for clinical treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No