NCT07349043 A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
| NCT ID | NCT07349043 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Peritoneal Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.)
Eligibility Criteria
Inclusion Criteria: 1. Patients with peritoneal metastatic adenocarcinoma of colorectal origin, confirmed by histopathology, and without metastasis to other sites. 2. No gender limitation, aged 18 to 75 years old; 3. ECOG score ≤2; 4. Subjects without other malignant diseases; 5. Subjects without laparoscopic surgery contraindications; 6. Expected survival period \> 6 months; 7. Able to comprehend and sign the informed consent form; 8. 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 Exclusion Criteria: 1. Subjects with gastrointestinal obstruction; 2. Subjects who rely entirely on parenteral nutrition; 3. Subjects with decompensated ascites; 4. Subjects with severe abdominal infection (peritonitis); 5. Subjects with extensive abdominal adhesion; 6. Subjects who underwent both tumor reduction surgery and gastrointestinal resection and reconstruction simultaneously; 7. Subjects with portal vein thrombosis; 8. Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart failure, ejection fraction less than 50%, refractory hypertension, etc.); 9. Previously allergic to chemotherapy drugs; 10. Individuals with severe heart and lung, liver and kidney, blood system, or mental illnesses, as well as those who abuse drugs; 11. Pregnant or lactating women; 12. Patients who have participated in or are currently participating in other clinical trials within 3 months; 13. Other situations where the researchers believe that the patient is not suitable to participate in this trial; 14. 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07349043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Peritoneal Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07349043 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07349043 currently recruiting?
Yes, NCT07349043 is actively recruiting participants. Contact the research team at sunlifeng@zju.edu.cn for enrollment information.
Where is the NCT07349043 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07349043 clinical trial?
NCT07349043 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 42 participants.