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NCT Number: NCT07544030

A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Advanced Epithelial Ovarian Cancer

Evaluation Compared with traditional NACT, whether PIPAC can increase the incidence of CRS3 determines the rationality of choosing PIPAC.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location status: Recruiting

Location contact

Zhentong Wei Medic

CONTACT

[email protected]

15804300686

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PIPAC

Procedure

This is a randomized, controlled, open, and parallel design clinical study aimed at evaluating the efficacy and safety of PIPAC. Sixty patients with stage IIIC-IVA high-grade serous ovarian cancer (HGSOC) were randomly assigned to either the traditional NACT or PIPAC group for treatment, and the incidence of CRS3 was then assessed. This study is exploratory, and statistical analysis will be conducted after all cases have been treated and followed up, providing a basis for future clinical studies.

Primary outcomes

  1. Can PIPAC increase the incidence of CRS3

    Time frame: Two years

    The primary objective of this study is to evaluate whether PIPAC can increase the incidence of CRS3 compared to traditional NACT, thereby determining the rationale for choosing PIPAC. The main evaluation metric is derived from the CRS scoring system. According to the ICCR guidelines, the CRS score is obtained through pathological analysis of the peritoneal tissue collected during IDS.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaosen Li Li

CONTACT

[email protected]

18343116682

Sponsors and collaborators

Lead sponsor

tongweihua

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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