NCT07349043RecruitingPhase 1
A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 4 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Colorectal cancer
- NCT number
- NCT07349043
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 42
- From 1 Jan 2026 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who underwent both tumor reduction surgery and gastrointestinal resection and reconstruction simultaneously;
- Previously allergic to chemotherapy drugs;
- 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;
Other illness
- Subjects with severe abdominal infection (peritonitis);
- Subjects with portal vein thrombosis;
- Individuals with severe heart and lung, liver and kidney, blood system, or mental illnesses, as well as those who abuse drugs;
Lab values
- Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart failure, ejection fraction less than 50%, refractory hypertension, etc.);
Other
- Subjects with gastrointestinal obstruction;
- Subjects who rely entirely on parenteral nutrition;
- Subjects with decompensated ascites;
- Subjects with extensive abdominal adhesion;
- 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;
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.