Pressurized intraperitoneal aerosol chemotherapy (PIPAC) versus standard neoadjuvant chemotherapy for advanced high-grade serous ovarian cancer
A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Advanced Epithelial Ovarian Cancer
This trial will test whether giving chemotherapy as a pressurized abdominal aerosol (PIPAC) before surgery helps women with advanced high-grade serous ovarian cancer get a stronger tumor response than standard pre-surgery chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT07544030 on ClinicalTrials.gov |
What this trial studies
This is a randomized, phase 3 trial comparing PIPAC—chemotherapy delivered as a pressurized intraperitoneal aerosol during laparoscopy—with traditional neoadjuvant systemic chemotherapy in women with FIGO stage IIIC–IVA high-grade serous ovarian cancer and high tumor burden. Eligible patients are adults 18–70 judged to need neoadjuvant therapy because upfront complete resection is unlikely or not tolerated, and must meet specified organ function and performance-status criteria. The primary focus is whether PIPAC increases the rate of a high chemotherapy response score (CRS3) before cytoreductive surgery, with safety and feasibility also monitored. Treatment and follow-up occur at a single center, with random assignment to PIPAC-based or standard neoadjuvant approaches and standardized surgical assessment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–70 with high-grade serous ovarian cancer at FIGO stage IIIC–IVA, a high intra-abdominal tumor burden (Fagotti and MD Anderson scores ≥8), adequate blood counts and organ function, and WHO performance status 0–2 who are planned for neoadjuvant therapy.
Not a fit: Patients with early-stage disease, non–high-grade serous histology, poor organ or bone marrow function, severe comorbidities, or those eligible for immediate complete (R0) resection are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, PIPAC could increase the number of patients who achieve a strong tumor response before surgery, making complete tumor removal more achievable and potentially improving outcomes.
How similar studies have performed: Smaller observational and early-phase PIPAC reports in peritoneal metastases, including ovarian cancer, have shown promising tumor responses and acceptable safety, but high-quality phase 3 evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with high-grade serous adenocarcinoma (HGSOC) with FIGO stage IIIC-IVA. 2. Age between 18 and 70. 3. 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. 4. Normal renal function (blood creatinine: 58-96 μmol/L). 5. 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). 6. Normal liver function (bilirubin 3.4-22.2 μmol/L, ALT 7-40 U/L, AST 13-35 U/L, AST/ALT≤ 1.5）。 7. World Health Organization Performance status score (WHO score) 0-2 points. Exclusion Criteria: * 1\) Patients with other malignancies or have received any form of chemotherapy, radiotherapy and targeted therapy for this disease in other hospitals. 2\) 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 this trial is running
Changchun, Jilin
- The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Xiaosen Li Li
- Email: xiaosensen@jlu.edu.cn
- Phone: 18343116682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.