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

NCT06496919 | Not Yet Recruiting

• 1 other identifier: PM-GCCC-TNF
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

rmhTNF, gastric cancer, colorectal cancer, peritoneal metastasis, intraperitoneal infusion chemotherapy

Outcome Measures

Primary Outcomes (4)

• Event-Free Survival (EFS)

  Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma

  after radical surgery for 1-3 years

• Progression-Free Survival （PFS）

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

  after radical surgery for 3 years

• Objective Response Rate

  Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma

  after radical surgery for 3 years

• Disease Control Rate

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

  4 weeks after administration

Secondary Outcomes (3)

• Overall Survival（OS）

  after radical surgery for 3 years

• Regional recurrence rate

  after radical surgery for 3 years

• Adverse events

  24 hours after administration

Study Arms (2)

Gastric malignant tumor queue

Drug: Recombinant Mutant Human Tumor Necrosis Factor

Colorectal Malignant Tumor Queue

Drug: Recombinant Mutant Human Tumor Necrosis Factor

Interventions

Recombinant Mutant Human Tumor Necrosis Factor DRUG

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

Colorectal Malignant Tumor Queue; Gastric malignant tumor queue

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. 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.

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Bin Xiong, Doctor

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChunWei Peng, Doctor

CONTACT

13476196566; whupengcw@whu.edu.cn

Bin Xiong, Doctor

CONTACT

13886029351; binxiong1961@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

CN (1)