Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06496919

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).
  • Patients with recurrent/metastatic gastric adenocarcinoma and colorectal cancer.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Recombinant Mutant Human Tumor Necrosis Factor

Drug

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

Primary outcomes

  1. Event-Free Survival (EFS)

    Time frame: after radical surgery for 1-3 years

    Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma

  2. Progression-Free Survival (PFS)

    Time frame: after radical surgery for 3 years

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

  3. Objective Response Rate

    Time frame: after radical surgery for 3 years

    Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma

  4. Disease Control Rate

    Time frame: 4 weeks after administration

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

Secondary outcomes

  1. Overall Survival(OS)

    Time frame: after radical surgery for 3 years

    Time from the first study treatment until death from any cause

  2. Regional recurrence rate

    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)

  3. Adverse events

    Time frame: 24 hours after administration

    The safety of rmhTNF intraperitoneal perfusion therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Xiong, Doctor

CONTACT

[email protected]

13886029351

ChunWei Peng, Doctor

CONTACT

[email protected]

13476196566

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

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.

Published trials that share one or more normalized conditions with this study.