A Prospective, Safety, and Efficacy Clinical Trial of Pressurized Intraperitoneal Aerosol Therapy for Peritoneal Metastasis of Colorectal Cancer

NCT07349043 | Recruiting Phase 1 DMC

• 1 other identifier: 2025-1055
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.)

Conditions

Peritoneal Metastasis; CRC (Colorectal Cancer)

Keywords

peritoneal metastasis; CRC; PIPAC

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  4 weeks

• Adverse Events (AEs)

  Monitoring and documenting all adverse events (e.g., nausea, fatigue, pain, hematological effects) following each dose escalation.

  up to 12 months

Secondary Outcomes (4)

• Maximum Plasma Concentration (Cmax)

  48h

• Objective Response Rate (ORR)

  up to 12 months

• Progression-Free Survival (PFS)

  up to 12 months

• Overall Survival (OS)

  up to 12 months

Study Arms (2)

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.

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.

Drug: Raltitrexed-PIPAC

Interventions

Mitomycin-PIPAC DRUG

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.

The MTD of PIPAC combined with mitomycin (MMS) in the treatment of CRCPM

Raltitrexed-PIPAC DRUG

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.

The MTD of PIPAC combined with raloxifene (RTX) in the treatment of CRCPM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China

Hangzhou, Other (Non U.s.), 310000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Lifeng Sun

CONTACT

86-(571)-8778-3586; sunlifeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)