A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China
RECRUITING
Hangzhou
Contact Information
Primary
Lifeng Sun
sunlifeng@zju.edu.cn
86-(571)-8778-3586
Time Frame
Start Date:2026-01
Estimated Completion Date:2028-10
Participants
Target number of participants:42
Treatments
Experimental: The MTD of PIPAC combined with mitomycin (MMS) in the treatment of CRCPM
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.
Experimental: The MTD of PIPAC combined with raloxifene (RTX) in the treatment of CRCPM
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.