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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Recombinant Mutant Human Tumor Necrosis Factor
  The patients who received rmhTNF intraperitoneal perfusion (intraperitoneal surgical field flushing perfusion or intraperitoneal thermal perfusion chemotherapy)

Первичные конечные точки

• Event-Free Survival (EFS) [Срок оценки: after radical surgery for 1-3 years]
• Progression-Free Survival （PFS） [Срок оценки: after radical surgery for 3 years]
• Objective Response Rate [Срок оценки: after radical surgery for 3 years]
• Disease Control Rate [Срок оценки: 4 weeks after administration]

Вторичные конечные точки (3)

• Overall Survival（OS） [Срок оценки: after radical surgery for 3 years]
• Regional recurrence rate [Срок оценки: after radical surgery for 3 years]
• Adverse events [Срок оценки: 24 hours after administration]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 1\. Individuals who are allergic to TNF, biological products, or penicillin; 2. Those who do not meet the inclusion criteria during pregnancy or lactation; 3. Other situations where the researcher believes that patients are not suitable to participate in this trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhongnan Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT06496919 · PM-GCCC-TNF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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