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A multicenter, prospective, single arm clinical trial on the safety and efficacy of sequential pressurized intraperitoneal aerosol chemotherapy with immunosuppressive agents and tocilizumab in the treatment of peritoneal metastatic adenocarcinoma

A multicenter, prospective, single arm clinical trial on the safety and efficacy of sequential pressurized intraperitoneal aerosol chemotherapy with immunosuppressive agents and tocilizumab in the treatment of peritoneal metastatic adenocarcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123267
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Peritoneal metastatic adenocarcinoma

Interventions

Group A (colorectal or appendix):None
Group B (stomach cancer or ovarian cancer):None

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients pathologically confirmed by histology to have peritoneal metastatic adenocarcinoma originating from the stomach, colorectal, or ovarian tissues, with intraoperative exploration PCI > 6; 2. Any gender, age 18–75 years; 3. ECOG score = 1.5 × 10^9/L, platelet count >= 80 × 10^9/L, hemoglobin >= 80 g/L; Blood biochemistry: total serum bilirubin 6 months; 8. Able to understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects with gastrointestinal obstruction; 2. Subjects fully dependent on parenteral nutrition; 3. Subjects with decompensated ascites; 4. Subjects with severe intra-abdominal infection (manifested as peritonitis); 5. Subjects with extensive intra-abdominal adhesions; 6. Subjects undergoing simultaneous tumor debulking surgery and gastrointestinal resection and reconstruction; 7. Subjects with portal vein thrombosis; 8. Subjects with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina, heart failure, ejection fraction below 50%, difficult-to-control hypertension, etc.); 9. Subjects with previous allergies to chemotherapy, PD-1 inhibitors, or PCSK9 inhibitors; 10. Subjects who have previously received PCSK9 inhibitor treatment for any indication; 11. Subjects with severe cardiopulmonary, hepatic, renal, hematologic, or psychiatric disorders, or history of substance abuse; 12. Pregnant or breastfeeding women; 13. Patients who have participated in or are currently participating in other clinical trials within 3 months; 14. Other conditions judged by the researcher to render the patient unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Safety observation during the trial, including the incidence of adverse events, serious adverse events, and device deficiencies.;

Secondary

MeasureTime frame
Rate of conversion therapy;Objective response rate (ORR);Peritoneal Cancer Index score;Postoperative pain score;Peritoneal Regression Grading Score;Quality of life status;Rate of ascites improvement;

Countries

China

Contacts

Public ContactLi Yong

Guangdong Provincial People's Hospital

liyong@gdph.org.cn+86 13822177479

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026