Gastric CancerNCT06496919
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
An observational study of Gastric Cancer, run by Wuhan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Recombinant Mutant Human Tumor Necrosis Factor
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
ChunWei Peng, Doctor, 13476196566, whupengcw@whu.edu.cn
Bin Xiong, Doctor, 13886029351, binxiong1961@whu.edu.cn
About this study
Official 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
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
- Being tested
- Recombinant Mutant Human Tumor Necrosis Factor
- Keywords
- rmhTNF, gastric cancer, colorectal cancer, peritoneal metastasis, intraperitoneal infusion chemotherapy
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Mutant Human Tumor Necrosis FactorDrug
The patients who received rmhTNF intraperitoneal perfusion (intraperitoneal surgical field flushing perfusion or intraperitoneal thermal perfusion chemotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Gastric malignant tumor queue | Not described Receives: Drug: Recombinant Mutant Human Tumor Necrosis Factor | |
| Colorectal Malignant Tumor Queue | Not described Receives: Drug: Recombinant Mutant Human Tumor Necrosis Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma
Measured: after radical surgery for 1-3 years
Progression-Free Survival （PFS）
Survival without peritoneal implant metastasis after radical surgery for gastric and colorectal adenocarcinoma
Measured: after radical surgery for 3 years
Objective Response Rate
Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma
Measured: after radical surgery for 3 years
Disease Control Rate
Disease Control Ratel rate of malignant ascites in gastric and colorectal adenocarcinoma
Measured: 4 weeks after administration
Secondary outcomes (3)
Overall Survival（OS）
Time from the first study treatment until death from any cause
Measured: after radical surgery for 3 years
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)
Measured: after radical surgery for 3 years
Adverse events
The safety of rmhTNF intraperitoneal perfusion therapy
Measured: 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Xiong, MD, Wuhan University
- Investigators
- Bin Xiong, Doctor, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496919
- Sponsor's protocol ID
- PM-GCCC-TNF
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06496919
- Acronym / sponsor ID
- PM-GCCC-TNF
- Conditions
- Gastric Cancer
- Keywords
- rmhTNF, gastric cancer, colorectal cancer, peritoneal metastasis, intraperitoneal infusion chemotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric malignant tumor queue | – | Drug: Recombinant Mutant Human Tumor Necrosis Factor |
| Colorectal Malignant Tumor Queue | – | Drug: Recombinant Mutant Human Tumor Necrosis Factor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The initial pathological diagnosis is gastric adenocarcinoma and colorectal adenocarcinoma, with clinical stage progression or advanced stage (cII-IV stage).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Mutant Human Tumor Necrosis FactorThe patients who received rmhTNF intraperitoneal perfusion (intraperitoneal surgical field flushing perfusion or intraperitoneal thermal perfusion chemotherapy) | Drug | Colorectal Malignant Tumor Queue, Gastric malignant tumor queue |
Primary outcome
Event-Free Survival (EFS)
Time frame: after radical surgery for 1-3 years
Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma
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
Objective Response Rate
Time frame: after radical surgery for 3 years
Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma
Disease Control Rate
Time frame: 4 weeks after administration
Disease Control Ratel rate of malignant ascites in gastric and colorectal adenocarcinoma
3 secondary outcomes
Overall Survival（OS）
Time frame: after radical surgery for 3 years
Regional recurrence rate
Time frame: after radical surgery for 3 years
Adverse events
Time frame: 24 hours after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bin Xiong, Doctor principal investigator
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ChunWei Peng, Doctor (13476196566, whupengcw@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: after radical surgery for 1-3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.