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

NCT07544030 | Recruiting DMC

• 1 other identifier: 25K213-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; PIPAC

Outcome Measures

Primary Outcomes (1)

• Can PIPAC increase the incidence of CRS3

  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

Study Arms (1)

A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized In

EXPERIMENTAL

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.

Procedure: PIPAC; Procedure: NACT

Interventions

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.

A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized In

NACT 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.

A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized In

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) Patients with other malignancies or have received any form of chemotherapy, radiotherapy and targeted therapy for this disease in other hospitals.

Sponsors & Collaborators

• tongweihua: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Xiaosen Li Li

CONTACT

18343116682; xiaosensen@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 22, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: April 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)