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A prospective, safety, efficacy and multicenter single-arm clinical trial of peritoneal metastatic adenocarcinoma pressurized abdominal aerosol chemotherapy (PIPAC)

A prospective, safety, efficacy and multicenter single-arm clinical trial of peritoneal metastatic adenocarcinoma pressurized abdominal aerosol chemotherapy (PIPAC)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111035
Enrollment
Unknown
Registered
2025-10-24
Start date
2025-02-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with peritoneal metastatic adenocarcinoma originated from the stomach and colorectal organs

Interventions

The PIPAC treatment group:PIPAC treatment

Sponsors

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with pathologically confirmed peritoneal metastatic adenocarcinoma originating from the stomach, colon, or rectum; 2. Any gender, age between 18 and 75 years; 3. At least one measurable tumor lesion according to RECIST 1.1 criteria; 4. ECOG performance status = 1.5 × 10^9/L, platelet count >= 80 × 10^9/L, hemoglobin >= 80 g/L, Biochemistry: total serum bilirubin 6 months; 9. Able to understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Subjects with digestive tract obstruction; 2.Subjects who rely solely on parenteral nutrition; 3.Subjects with compensated ascites and associated with decompensated ascites; 4.Subjects with severe abdominal cavity infection (manifestations of peritonitis); 5.Subjects with extensive peritoneal adhesions; 6.Subjects who simultaneously underwent tumor resection and digestive tract resection and reconstruction surgery; 7.Subjects with portal vein thrombosis combined; 8.History of allergy to chemotherapy drugs; 9.Those with serious diseases of the heart and lungs, liver and kidneys, blood system or mental health, and those who abuse drugs; 10.Pregnant or lactating women; 11.Patients who have participated in or are currently participating in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse reactions;Postoperative pain score (VAS score);Quality of life situation;

Secondary

MeasureTime frame
overall survival;Pathological remission rate (PRGS);

Countries

China

Contacts

Public ContactWang Guihua

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

ghwang@tjh.tjmu.edu.cn+86 150 7145 9503

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026