Peritoneal metastatic adenocarcinoma
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Safety observation during the trial, including the incidence of adverse events, serious adverse events, and device deficiencies.; | — |
Secondary
| Measure | Time 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
Guangdong Provincial People's Hospital