Pressurized intraperitoneal aerosol chemotherapy (PIPAC) versus standard neoadjuvant chemotherapy for advanced high-grade serous ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Xiaosen Li Li
• Email: xiaosensen@jlu.edu.cn
• Phone: 18343116682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• VT-101 in Advanced Ovarian Cancer: early safety study in adults

  This early-phase trial tests VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer to see if it is safe, how the body handles it, and whether there are any initial signs of activity.

  Recruiting Phase 1 University of Iowa · Iowa City, Iowa · NCT07905677

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

• EHR-based approach to boost HBOC genetic testing in at-risk women

  A new EHR tool-based program tests whether computer prompts and real patient resources can help more women with family histories of breast or ovarian cancer get HBOC genetic testing.

  Recruiting Columbia University · New York, New York · NCT07876349

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.