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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorWuhan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Recombinant Mutant Human Tumor Necrosis Factor

    Drug

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Gastric malignant tumor queue1 intervention
Group B: Colorectal Malignant Tumor Queue1 intervention

Trial outcomes

Primary outcomes

1

Event-Free Survival (EFS)

Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma

Time frame
after radical surgery for 1-3 years
2

Progression-Free Survival (PFS)

Survival without peritoneal implant metastasis after radical surgery for gastric and colorectal adenocarcinoma

Time frame
after radical surgery for 3 years
3

Objective Response Rate

Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma

Time frame
after radical surgery for 3 years
4

Disease Control Rate

Disease Control Ratel rate of malignant ascites in gastric and colorectal adenocarcinoma

Time frame
4 weeks after administration

Secondary outcomes

1

Overall Survival(OS)

Time from the first study treatment until death from any cause

Time frame
after radical surgery for 3 years
2

Regional recurrence rate

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
after radical surgery for 3 years
3

Adverse events

The safety of rmhTNF intraperitoneal perfusion therapy

Time frame
24 hours after administration

Other outcomes

Sponsors and contacts

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