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

May 6, 2026 updated by: tongweihua
Evaluation Compared with traditional NACT, whether PIPAC can increase the incidence of CRS3 determines the rationality of choosing PIPAC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
The treatment group received PIPAC plus intravenous NACT (paclitaxel or docetaxel plus two cycles of carboplatin)
Procedure: PIPAC
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.
No Intervention: control group
The control group received intravenous NACT (paclitaxel or docetaxel plus carboplatin for three cycles)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

tongweihua

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

November 10, 2027

Study Completion (Estimated)

November 10, 2027

Study Registration Dates

First Submitted

March 21, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25K213-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on PIPAC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe