Peritoneal MetastasesPhase 2NCT05755685
Hyperthermic Intraperitoneal Treatment of rmhTNF for CRCPM: Phase II Clinical Trial
A Phase 2 study testing Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF) in people with Peritoneal Metastases and Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this study is planing to adopt intra-abdominal perfusion therapy of rmhTNF during radical colorectal cancer surgery to determine whether intra-abdominal therapy has an impact on postoperative intestinal function recovery, anastomotic leakage, postoperative bleeding, postoperative adhesion intestinal… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peritoneal Metastases, Colorectal Cancer
- What is being tested?
- Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2023to 1 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adenocarcinoma of colonic and peritoneal reflexive superior rectum was confirmed by pathology, aged 18-70 years;
- Body condition score (PS) 0 ~ 1 in the Eastern Tumor Collaboration Group (ECOG);
- Preoperative clinical stage was M1c;
- No neoadjuvant therapy was performed;
- Histopathologically confirmed as peritoneal metastases of colorectal cancer > 10cm from the anus, R0-resected, adenocarcinoma/mucinous adenocarcinoma
- The functions of vital organs shall meet the following requirements;
- Be able to understand the situation of this study and sign informed consent.
Who cannot join
- Allergic history of TNF and its derivatives;
- Patients with fever (>38℃);
- Active hepatitis and peripheral neuropathy (e.g., peripheral neuritis, pseudomeningitis, motor neuritis, and sensory disorders);
- Pregnant or lactating women, or potentially pregnant women and sexually active men who refuse/cannot receive medically acceptable forms of contraception;
- Patients with a history of malignant tumor;
- Clinical symptoms or diseases of the heart that are not well controlled.
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- Subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism;
- The subject has a known history of psychotropic substance abuse, alcoholism or drug use; Subjects innate or acquired immune function defects (such as HIV infection), or active hepatitis
- Other conditions in which the investigator thinks the patient should not participate in the study;
- A history of neurological or psychiatric disorders, such as major depression or dementia, that may affect the informed study or follow-up evaluation;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Lifeng Sun, Dr.
About this study
Official title: Hyperthermic Intraperitoneal Treatment of Recombinant Modified Human Tumor Necrosis Factor (rmhTNF) for Colorectal Cancer With Peritoneal Metastases: Phase II Clinical Trial
The goal of this study is planing to adopt intra-abdominal perfusion therapy of rmhTNF during radical colorectal cancer surgery to determine whether intra-abdominal therapy has an impact on postoperative intestinal function recovery, anastomotic leakage, postoperative bleeding, postoperative adhesion intestinal obstruction and other complications. On this basis, the effect of rmhTNF on postoperative peritoneal implantation metastasis and long-term survival was further studied. The main question it aims to answer is: To evaluate the safety and efficacy of rmhTNF in the treatment of peritoneal metastases in colorectal cancer. Participants will receive 1. Radical surgery: Surgical methods can be developed or endoscopic (including robotic surgery). Radical resection of colorectal cancer (corresponding resection of colon and rectum plus regional lymph node dissection, regional lymph node dissection including parenteral, intermediate and mesangial root lymph nodes) follows the principle of mesangectomy and tumorless operation. 2. Abdominal heat perfusion was performed twice: the first time, 5 million IUrmhTNF, dissolved in 30-50ml normal saline, was intraperitoneal heat perfusion into the surgical focus after the operation; the second time, rhatitrexed 2.5mg/m2 was injected into the abdominal cavity through thermoperfusion or drainage tube; 3. Postoperative systemic chemotherapy regimen: postoperative adjuvant chemotherapy should be started 3-4 weeks after surgery, and appropriately extended for patients with poor physique, but no later than 8 weeks after surgery. The chemotherapy regimen was determined by the clinician according to pathological stage, molecular typing, and risk factors, referring to the NCCN and CSCO guidelines.
- Conditions
- Peritoneal Metastases, Colorectal Cancer
- Being tested
- Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF)
- Keywords
- Colorectal Cancer, Peritoneal metastasis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF)Drug
5 million IUrmhTNF, dissolved in 30-50ml normal saline, was intraperitoneal heat perfusion into the surgical focus after the operation;
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | The preoperative clinical stage was M1c colon or peritoneal retroflex superior rectum adenocarcinoma Receives: Drug: Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, the time of postoperative intestinal function recovery, whether exist anastomotic leakage, postoperative bleeding, postoperative adhesion ileus, and other complications in 2 weeks after surgery.
Measured: 1 year
Secondary outcomes (1)
the recurrence rate of metastasis and long-term survival of participants accepted the treatment of rmhTNF in the treatment of peritoneal metastases in colorectal cancer.
- record the time period between the date of randomization and the date of patient tumor recurrence or death (earliest occurrence), and calculated the recurrence rate of metastasis after surgery.
- 1-year overall survival rate after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start10 Feb 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Weike Biopharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lifeng Sun, Dr, Study chair, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755685
- Sponsor's protocol ID
- 2022-0966
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 6 Mar 2023
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperthermic Intraperitoneal Treatment of Recombinant Modified Human Tumor Necrosis Factor (rmhTNF) for Colorectal Cancer With Peritoneal Metastases: Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05755685
- Acronym / sponsor ID
- 2022-0966
- Conditions
- Peritoneal Metastases, Colorectal Cancer
- Keywords
- Colorectal Cancer, Peritoneal metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Weike Biopharmaceutical Co., Ltd.
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 6 Mar 2023 (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.
The goal of this study is planing to adopt intra-abdominal perfusion therapy of rmhTNF during radical colorectal cancer surgery to determine whether intra-abdominal therapy has an impact on postoperative intestinal function recovery, anastomotic leakage, postoperative bleeding, postoperative adhesion intestinal obstruction and other complications. On this basis, the effect of rmhTNF on postoperative peritoneal implantation metastasis and long-term survival was further studied. The main question it aims to answer is: To evaluate the safety and efficacy of rmhTNF in the treatment of peritoneal metastases in colorectal cancer. Participants will receive 1. Radical surgery: Surgical methods can be developed or endoscopic (including robotic surgery). Radical resection of colorectal cancer (corresponding resection of colon and rectum plus regional lymph node dissection, regional lymph node dissection including parenteral, intermediate and mesangial root lymph nodes) follows the principle of mesangectomy and tumorless operation. 2. Abdominal heat perfusion was performed twice: the first time, 5 million IUrmhTNF, dissolved in 30-50ml normal saline, was intraperitoneal heat perfusion into the surgical focus after the operation; the second time, rhatitrexed 2.5mg/m2 was injected into the abdominal cavity through thermoperfusion or drainage tube; 3. Postoperative systemic chemotherapy regimen: postoperative adjuvant chemotherapy should be started 3-4 weeks after surgery, and appropriately extended for patients with poor physique, but no later than 8 weeks after surgery. The chemotherapy regimen was determined by the clinician according to pathological stage, molecular typing, and risk factors, referring to the NCCN and CSCO guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF)The preoperative clinical stage was M1c colon or peritoneal retroflex superior rectum adenocarcinoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adenocarcinoma of colonic and peritoneal reflexive superior rectum was confirmed by pathology, aged 18-70 years;
- Body condition score (PS) 0 ~ 1 in the Eastern Tumor Collaboration Group (ECOG);
- Preoperative clinical stage was M1c;
- No neoadjuvant therapy was performed;
- Histopathologically confirmed as peritoneal metastases of colorectal cancer > 10cm from the anus, R0-resected, adenocarcinoma/mucinous adenocarcinoma
Key exclusion criteria (10 listed)
- Allergic history of TNF and its derivatives;
- Patients with fever (>38℃);
- Active hepatitis and peripheral neuropathy (e.g., peripheral neuritis, pseudomeningitis, motor neuritis, and sensory disorders);
- Pregnant or lactating women, or potentially pregnant women and sexually active men who refuse/cannot receive medically acceptable forms of contraception;
- Patients with a history of malignant tumor;
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 |
|---|---|---|
| Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF)5 million IUrmhTNF, dissolved in 30-50ml normal saline, was intraperitoneal heat perfusion into the surgical focus after the operation; | Drug | Group1 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, the time of postoperative intestinal function recovery, whether exist anastomotic leakage, postoperative bleeding, postoperative adhesion ileus, and other complications in 2 weeks after surgery.
1 secondary outcome
the recurrence rate of metastasis and long-term survival of participants accepted the treatment of rmhTNF in the treatment of peritoneal metastases in colorectal cancer.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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. This study is not recruiting at the moment.
Lifeng Sun, Dr study chair
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF) in people with Peritoneal Metastases and Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lifeng Sun, Dr. (139 5810 3041, sunlifeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 1 year). 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 6 Mar 2023.