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OncoMatch/Clinical Trials/NCT07349043

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

Is NCT07349043 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Mitomycin-PIPAC and Raltitrexed-PIPAC for peritoneal metastasis.

Phase 1RecruitingSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNCT07349043Data as of May 2026

Treatment: Mitomycin-PIPAC · Raltitrexed-PIPACFor 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.)

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Lab requirements

Blood counts

ANC ≥1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥8.0g/dl (acceptable if achieved by transfusion/intervention); serum albumin ≥2.8g/dL

Kidney function

Creatinine clearance rate ≥50mL/min

Liver function

Bilirubin ≤1.5 times ULN, ALT and AST ≤1.5 times ULN; if there is liver metastasis, ALT and AST ≤5 times ULN

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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