Peritoneal MetastasisPhase 1NCT07349043
A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
A Phase 1 study testing Mitomycin-PIPAC and Raltitrexed-PIPAC in people with Peritoneal Metastasis and CRC (Colorectal Cancer), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
For colorectal cancer with peritoneal metastasis, the current first-line standard treatment offers very limited benefits and short survival. Therefore, it is necessary to seek new treatment strategies to improve the prognosis and survival of such patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Metastasis, CRC (Colorectal Cancer)
- What is being tested?
- Mitomycin-PIPAC and Raltitrexed-PIPAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Oct 2028
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with peritoneal metastatic adenocarcinoma of colorectal origin, confirmed by histopathology, and without metastasis to other sites.
- No gender limitation, aged 18 to 75 years old;
- ECOG score ≤2;
- Subjects without other malignant diseases;
- Subjects without laparoscopic surgery contraindications;
- Expected survival period > 6 months;
- Able to comprehend and sign the informed consent form;
- The function of important organs should meet the following requirements; The absolute neutrophil count (ANC) is ≥1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥8.0g/dl (Note: It is acceptable to achieve hemoglobin ≥8.0g/dl through blood transfusion or other interventions); serum albumin ≥2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST ≤1.5 times ULN; if there is liver metastasis, ALT and AST ≤5 times ULN; Creatinine clearance rate ≥50mL/min
Who cannot join
- Subjects with gastrointestinal obstruction;
- Subjects who rely entirely on parenteral nutrition;
- Subjects with decompensated ascites;
- Subjects with severe abdominal infection (peritonitis);
- Subjects with extensive abdominal adhesion;
- Subjects who underwent both tumor reduction surgery and gastrointestinal resection and reconstruction simultaneously;
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- Subjects with portal vein thrombosis;
- Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart failure, ejection fraction less than 50%, refractory hypertension, etc.);
- Previously allergic to chemotherapy drugs;
- Individuals with severe heart and lung, liver and kidney, blood system, or mental illnesses, as well as those who abuse drugs;
- Pregnant or lactating women;
- Patients who have participated in or are currently participating in other clinical trials within 3 months;
- Other situations where the researchers believe that the patient is not suitable to participate in this trial;
- Previously had a history of neurological or psychiatric disorders that would affect study informed consent or follow-up evaluation, such as severe depression or dementia;
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, 1 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China
Hangzhou, Other (Non U.s.), 310000
Lifeng Sun, 86-(571)-8778-3586, sunlifeng@zju.edu.cn
About this study
For colorectal cancer with peritoneal metastasis, the current first-line standard treatment offers very limited benefits and short survival. Therefore, it is necessary to seek new treatment strategies to improve the prognosis and survival of such patients. Based on previous basic research and early clinical research results, the strategy of PIPAC combined with MMC or RTX provides a feasible solution that can benefit patients with advanced colorectal cancer and peritoneal metastasis undergoing first-line treatment. This study aims to evaluate the effectiveness of PIPAC combined with MMC or RTX as first-line treatment for patients with colorectal cancer and peritoneal metastasis, while ensuring that patients receive standard first-line treatment. (The main purpose of the proposed Phase I trial is to determine the MTD of PIPAC combined with MMC or RTX and evaluate the safety of combining it with systemic chemotherapy for patients with colorectal cancer and peritoneal metastasis.)
Read the detailed description
- Research background Colorectal cancer (CRC) is one of the most common malignant tumors. Globally, approximately 1 million new cases of colorectal cancer occur each year, and about 500,000 people die from the disease annually. With the improvement of living standards and changes in lifestyle habits, the incidence rate of colorectal cancer is gradually increasing, posing a serious threat to human life. To prevent the occurrence of peritoneal metastasis, based on previous basic research and early clinical research results, the strategy of PIPAC combined with MMC or raltitrexed provides a feasible approach that can benefit patients with advanced colorectal cancer who undergo first-line treatment for peritoneal metastasis.
- Research purpose To evaluate the safety and determine the maximum tolerated dose (MTD) of pressurized intraperitoneal aerosol chemotherapy combined with mitomycin or raltitrexed in patients with colorectal cancer and peritoneal metastasis.
II. Specific Procedures and Processes
- Treatment method This trial is a prospective study, and the subjects are patients diagnosed with peritoneal metastasis of colorectal cancer. Mitomycin-PIPAC group: Mitomycin (increasing doses: 5mg/m2, 10mg/m2, 15mg/m2, 20mg/m2) + 0.9% saline 50 mL was administered via intraperitoneal aerosol chemotherapy under pressure. Raltitrexed-PIPAC group: Raltitrexed (dose escalation: 1mg/m2, 1.5mg/m2, 2mg/m2, 2.5mg/m2, 3mg/m2) + 0.9% saline 50 mL for pressurized intraperitoneal aerosol chemotherapy. PIPAC frequency: 1 time/4-6W, continuous treatment for 3 courses (if the subject is unable to undergo the second or third PIPAC, the investigator needs to record the reason). Equipment: Pressure Intraperitoneal Aerosol Chemotherapy (PIPAC) equipment includes an endoscope pulse irrigation device and its supporting instruments, mainly including a display screen, an infusion rack, a liquid sensor, a high-pressure peristaltic pump, and the main structure of the machine; supporting instruments include: 10 mm atomizing nozzle, high-pressure infusion tube, infusion tube puncture head, and 10/12 mm trocar puncture device (2). Surgical plan The principle of mesenteric resection and tumor-free operation should be followed in tumor reduction surgery. systemic chemotherapy regimen The chemotherapy regimen is determined by the clinician based on pathological staging, molecular typing, risk factors, and in accordance with the NCCN and CSCO guidelines.
- Visit and follow-up Patients came to the hospital for follow-up visits according to the requirements of the research protocol and continued until the end of the study.
- Conditions
- Peritoneal Metastasis, CRC (Colorectal Cancer)
- Being tested
- Mitomycin-PIPAC, Raltitrexed-PIPAC
- Keywords
- peritoneal metastasis, CRC, PIPAC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin-PIPACDrug
Mitomycin-PIPAC group: The patients were treated with mitomycin (increasing dose: 5mg/m2, 10mg/m2, 15mg/m2, 20mg/m2) + 0.9% saline 50 mL by pressurized intraperitoneal aerosol chemotherapy.
Raltitrexed-PIPACDrug
Raltitrexed-PIPAC group: Raltitrexed (dose escalation: 1mg/m2, 1.5mg/m2, 2mg/m2, 2.5mg/m2, 3mg/m2) + 0.9% saline 50 mL for pressurized intraperitoneal aerosol chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| The MTD of PIPAC combined with mitomycin (MMS) in the treatment of CRCPM | Experimental | This trial is a prospective study, and the subjects are patients diagnosed with peritoneal metastasis of colorectal cancer.
Mitomycin-PIPAC group: The patients were treated with mitomycin (increasing dose: 5mg/m2, 10mg/m2, 15mg/m2, 20mg/m2) + 0.9% saline 50 mL by pressurized intraperitoneal aerosol chemotherapy.
PIPAC frequency: 1 time/4-6W, continuous treatment for 3 courses (if the subject is unable to undergo the second or third PIPAC, the investigator needs to record the reason).
3.6.2 Surgical plan The principle of mesenteric resection and tumor-free operation should be followed in tumor reduction surgery.
3.6.3 Systemic chemotherapy regimen The chemotherapy regimen is determined by clinicians based on pathological staging, molecular typing, risk factors, and in accordance with the guidelines of the NCCN and CSCO. Receives: Drug: Mitomycin-PIPAC |
| The MTD of PIPAC combined with raloxifene (RTX) in the treatment of CRCPM | Experimental | This trial is a prospective study, and the subjects are patients diagnosed with peritoneal metastasis of colorectal cancer.
Raltitrexed-PIPAC group: Raltitrexed (dose escalation: 1mg/m2, 1.5mg/m2, 2mg/m2, 2.5mg/m2, 3mg/m2) + 0.9% saline 50 mL for pressurized intraperitoneal aerosol chemotherapy.
PIPAC frequency: 1 time/4-6W, continuous treatment for 3 courses (if the subject is unable to undergo the second or third PIPAC, the investigator needs to record the reason).
3.6.2 Surgical plan The principle of mesenteric resection and tumor-free operation should be followed in tumor reduction surgery.
3.6.3 Systemic chemotherapy regimen The chemotherapy regimen is determined by clinicians based on pathological staging, molecular typing, risk factors, and in accordance with the guidelines of the NCCN and CSCO. Receives: Drug: Raltitrexed-PIPAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
The number and severity of toxicities observed during treatment, as well as their relation to the dose level of MMS or RTX administered via PIPAC.
Measured: the first 4 weeks
Maximum Tolerated Dose (MTD)
MTD will be determined based on the highest dose administered where <33% of patients experience DLTs, or by dose-escalation schemes according to standard practices.
Measured: 4 weeks
Adverse Events (AEs)
Monitoring and documenting all adverse events (e.g., nausea, fatigue, pain, hematological effects) following each dose escalation.
Measured: up to 12 months
Secondary outcomes (4)
Maximum Plasma Concentration (Cmax)
To measure the highest plasma concentration of mitomycin (MMS) or raltitrexed (RTX) after PIPAC administration.
Measured: 48h
Objective Response Rate (ORR)
Measured using imaging techniques and clinical assessment to determine the proportion of patients who achieve complete or partial response.
Measured: up to 12 months
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death from any cause.
Measured: up to 12 months
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349043
- Sponsor's protocol ID
- 2025-1055
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy concerns and the sensitive nature of the health information collected, which cannot be sufficiently de-identified for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07349043
- Acronym / sponsor ID
- 2025-1055
- Conditions
- Peritoneal Metastasis, CRC (Colorectal Cancer)
- Keywords
- peritoneal metastasis, CRC, PIPAC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Jan 2026 (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.
For colorectal cancer with peritoneal metastasis, the current first-line standard treatment offers very limited benefits and short survival. Therefore, it is necessary to seek new treatment strategies to improve the prognosis and survival of such patients. Based on previous basic research and early clinical research results, the strategy of PIPAC combined with MMC or RTX provides a feasible solution that can benefit patients with advanced colorectal cancer and peritoneal metastasis undergoing first-line treatment. This study aims to evaluate the effectiveness of PIPAC combined with MMC or RTX as first-line treatment for patients with colorectal cancer and peritoneal metastasis, while ensuring that patients receive standard first-line treatment. (The main purpose of the proposed Phase I trial is to determine the MTD of PIPAC combined with MMC or RTX and evaluate the safety of combining it with systemic chemotherapy for patients with colorectal cancer and peritoneal metastasis.)
Detailed description
- Research background Colorectal cancer (CRC) is one of the most common malignant tumors. Globally, approximately 1 million new cases of colorectal cancer occur each year, and about 500,000 people die from the disease annually. With the improvement of living standards and changes in lifestyle habits, the incidence rate of colorectal cancer is gradually increasing, posing a serious threat to human life. To prevent the occurrence of peritoneal metastasis, based on previous basic research and early clinical research results, the strategy of PIPAC combined with MMC or raltitrexed provides a feasible approach that can benefit patients with advanced colorectal cancer who undergo first-line treatment for peritoneal metastasis.
- Research purpose To evaluate the safety and determine the maximum tolerated dose (MTD) of pressurized intraperitoneal aerosol chemotherapy combined with mitomycin or raltitrexed in patients with colorectal cancer and peritoneal metastasis.
II. Specific Procedures and Processes
- Treatment method This trial is a prospective study, and the subjects are patients diagnosed with peritoneal metastasis of colorectal cancer. Mitomycin-PIPAC group: Mitomycin (increasing doses: 5mg/m2, 10mg/m2, 15mg/m2, 20mg/m2) + 0.9% saline 50 mL was administered via intraperitoneal aerosol chemotherapy under pressure. Raltitrexed-PIPAC group: Raltitrexed (dose escalation: 1mg/m2, 1.5mg/m2, 2mg/m2, 2.5mg/m2, 3mg/m2) + 0.9% saline 50 mL for pressurized intraperitoneal aerosol chemotherapy. PIPAC frequency: 1 time/4-6W, continuous treatment for 3 courses (if the subject is unable to undergo the second or third PIPAC, the investigator needs to record the reason). Equipment: Pressure Intraperitoneal Aerosol Chemotherapy (PIPAC) equipment includes an endoscope pulse irrigation device and its supporting instruments, mainly including a display screen, an infusion rack, a liquid sensor, a high-pressure peristaltic pump, and the main structure of the machine; supporting instruments include: 10 mm atomizing nozzle, high-pressure infusion tube, infusion tube puncture head, and 10/12 mm trocar puncture device (2). Surgical plan The principle of mesenteric resection and tumor-free operation should be followed in tumor reduction surgery. systemic chemotherapy regimen The chemotherapy regimen is determined by the clinician based on pathological staging, molecular typing, risk factors, and in accordance with the NCCN and CSCO guidelines.
- Visit and follow-up Patients came to the hospital for follow-up visits according to the requirements of the research protocol and continued until the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The MTD of PIPAC combined with mitomycin (MMS) in the treatment of CRCPM | Experimental | Drug: Mitomycin-PIPACThis trial is a prospective study, and the subjects are patients diagnosed with peritoneal metastasis of colorectal cancer. Mitomycin-PIPAC group: The patients were treated with mitomycin (increasing dose: 5mg/m2, 10mg/m2, 15mg/m2, 20mg/m2) + 0.9% saline 50 mL by pressurized intraperitoneal aerosol chemotherapy. PIPAC frequency: 1 time/4-6W, continuous treatment for 3 courses (if the subject is unable to undergo the second or third PIPAC, the investigator needs to record the reason). 3.6.2 Surgical plan The principle of mesenteric resection and tumor-free operation should be followed in tumor reduction surgery. 3.6.3 Systemic chemotherapy regimen The chemotherapy regimen is determined by clinicians based on pathological staging, molecular typing, risk factors, and in accordance with the guidelines of the NCCN and CSCO. |
| The MTD of PIPAC combined with raloxifene (RTX) in the treatment of CRCPM | Experimental | Drug: Raltitrexed-PIPACThis trial is a prospective study, and the subjects are patients diagnosed with peritoneal metastasis of colorectal cancer. Raltitrexed-PIPAC group: Raltitrexed (dose escalation: 1mg/m2, 1.5mg/m2, 2mg/m2, 2.5mg/m2, 3mg/m2) + 0.9% saline 50 mL for pressurized intraperitoneal aerosol chemotherapy. PIPAC frequency: 1 time/4-6W, continuous treatment for 3 courses (if the subject is unable to undergo the second or third PIPAC, the investigator needs to record the reason). 3.6.2 Surgical plan The principle of mesenteric resection and tumor-free operation should be followed in tumor reduction surgery. 3.6.3 Systemic chemotherapy regimen The chemotherapy regimen is determined by clinicians based on pathological staging, molecular typing, risk factors, and in accordance with the guidelines of the NCCN and CSCO. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with peritoneal metastatic adenocarcinoma of colorectal origin, confirmed by histopathology, and without metastasis to other sites.
- No gender limitation, aged 18 to 75 years old;
- ECOG score ≤2;
- Subjects without other malignant diseases;
- Subjects without laparoscopic surgery contraindications;
Key exclusion criteria (14 listed)
- Subjects with gastrointestinal obstruction;
- Subjects who rely entirely on parenteral nutrition;
- Subjects with decompensated ascites;
- Subjects with severe abdominal infection (peritonitis);
- Subjects with extensive abdominal adhesion;
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 |
|---|---|---|
| Mitomycin-PIPACMitomycin-PIPAC group: The patients were treated with mitomycin (increasing dose: 5mg/m2, 10mg/m2, 15mg/m2, 20mg/m2) + 0.9% saline 50 mL by pressurized intraperitoneal aerosol chemotherapy. | Drug | The MTD of PIPAC combined with mitomycin (MMS) in the treatment of CRCPM |
| Raltitrexed-PIPACRaltitrexed-PIPAC group: Raltitrexed (dose escalation: 1mg/m2, 1.5mg/m2, 2mg/m2, 2.5mg/m2, 3mg/m2) + 0.9% saline 50 mL for pressurized intraperitoneal aerosol chemotherapy. | Drug | The MTD of PIPAC combined with raloxifene (RTX) in the treatment of CRCPM |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: the first 4 weeks
The number and severity of toxicities observed during treatment, as well as their relation to the dose level of MMS or RTX administered via PIPAC.
Maximum Tolerated Dose (MTD)
Time frame: 4 weeks
MTD will be determined based on the highest dose administered where <33% of patients experience DLTs, or by dose-escalation schemes according to standard practices.
Adverse Events (AEs)
Time frame: up to 12 months
Monitoring and documenting all adverse events (e.g., nausea, fatigue, pain, hematological effects) following each dose escalation.
4 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 48h
Objective Response Rate (ORR)
Time frame: up to 12 months
Progression-Free Survival (PFS)
Time frame: up to 12 months
Overall Survival (OS)
Time frame: up to 12 months
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 16 Jan 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy concerns and the sensitive nature of the health information collected, which cannot be sufficiently de-identified for sharing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitomycin-PIPAC and Raltitrexed-PIPAC in people with Peritoneal Metastasis and CRC (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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lifeng Sun (86-(571)-8778-3586, sunlifeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: the first 4 weeks). The study lists 3 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 16 Jan 2026.