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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Xiaosen Li Li
xiaosensen@jlu.edu.cn
18343116682
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2027-11-10
Participants
Target number of participants: 60
Treatments
Experimental: experimental group
The treatment group received PIPAC plus intravenous NACT (paclitaxel or docetaxel plus two cycles of carboplatin)
No_intervention: control group
The control group received intravenous NACT (paclitaxel or docetaxel plus carboplatin for three cycles)
Related Therapeutic Areas
Sponsors
Leads: tongweihua

This content was sourced from clinicaltrials.gov

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