A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Advanced Epithelial Ovarian Cancer
Recruiting now · Phase 3
Conditions studied: Ovarian Cancer
In brief
Evaluation Compared with traditional NACT, whether PIPAC can increase the incidence of CRS3 determines the rationality of choosing PIPAC.
Key facts
- Study ID
- NCT07544030
- Run by
- tongweihua
- People needed
- 60
- Starts
- 2025-11-10
- Expected to finish
- 2027-11-10
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients with high-grade serous adenocarcinoma (HGSOC) with FIGO stage IIIC-IVA.
- Age between 18 and 70.
- Patients were evaluated with Fagotti score and MD Anderson score. MD Anderson score was consistent with Fagotti score ≥ 8, which was evaluated as high tumor load, because the initial curative resection could not achieve R0 resection and NACT was selected; or patients could not tolerate the initial surgery due to severe complications and NACT was selected.
- Normal renal function (blood creatinine: 58-96 μmol/L).
- No bone marrow suppression (HBG ≥ 110 g/L, white blood cell count ≥ 4.0×109/L, neutropenia Granulocyte count greater than or equal to 2.0x109/L and platelet count greater than or equal to 100x109/L).
- Normal liver function (bilirubin 3.4-22.2 μmol/L, ALT 7-40 U/L, AST 13-35 U/L, AST/ALT≤ 1.5）。
- World Health Organization Performance status score (WHO score) 0-2 points.
You may not qualify if…
- 1) Patients with other malignancies or have received any form of chemotherapy, radiotherapy and targeted therapy for this disease in other hospitals.
- Diagnose complete intestinal obstruction. 3) Subjects who rely entirely on parenteral nutrition. 4) Subjects with decompensated ascites; 5) Subjects with severe abdominal infection (peritonitis); 6) Subjects with extensive adhesions in the abdominal cavity; 7) Subjects who underwent tumor debulking surgery and gastrointestinal resection reconstruction simultaneously; 8) Subjects with portal vein thrombosis; 9) Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart Functional insufficiency, ejection fraction less than 50%, difficult to control hypertension, etc.); 10) Allergy to chemotherapy drugs in the past; 11) Patients with serious cardiopulmonary, liver and kidney, blood system or mental illness and drug abuse; 12) Expected life is less than 12 weeks. 13) Patients who have participated or are currently participating in other clinical trials within 3 months; 14）Other conditions that the researchers judged the patient to be unsuitable for inclusion.
Where it is running
- The First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
Full record on ClinicalTrials.gov
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