Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT07544030

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

Led by tongweihua · Updated on 2026-05-11

60

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with high-grade serous adenocarcinoma (HGSOC) with FIGO stage IIIC-IVA.
  • Age between 18 and 70.
  • Evaluated with Fagotti score and MD Anderson score; MD Anderson score consistent with Fagotti score 8 or higher, indicating high tumor load and selection for NACT due to inability to achieve R0 resection or intolerance of initial surgery.
  • Normal renal function (blood creatinine: 58-96 bcmol/L).
  • No bone marrow suppression (hemoglobin 110 g/L, white blood cell count 4.0x109/L, neutrophil count 2.0x109/L, platelet count 100x109/L).
  • Normal liver function (bilirubin 3.4-22.2 bcmol/L, ALT 7-40 U/L, AST 13-35 U/L, AST/ALT 1.5).
  • World Health Organization Performance status score 0-2 points.
Not Eligible

You will not qualify if you...

  • Patients with other malignancies or prior chemotherapy, radiotherapy, or targeted therapy for this disease at other hospitals.
  • Complete intestinal obstruction.
  • Dependence entirely on parenteral nutrition.
  • Decompensated ascites.
  • Severe abdominal infection (peritonitis).
  • Extensive adhesions in the abdominal cavity.
  • Underwent tumor debulking surgery and gastrointestinal resection reconstruction simultaneously.
  • Portal vein thrombosis.
  • Severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart functional insufficiency with ejection fraction less than 50%, difficult to control hypertension).
  • Allergy to chemotherapy drugs in the past.
  • Serious cardiopulmonary, liver, kidney, blood system, or mental illness and drug abuse.
  • Expected life expectancy less than 12 weeks.
  • Participation in other clinical trials within the past 3 months.
  • Other conditions judged by researchers as unsuitable for inclusion.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Hospital of Jilin University

Changchun, Jilin, China, 130000

Actively Recruiting

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Research Team

X

Xiaosen Li Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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