NCT07273396

Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer

A Phase 1/2a Study to Evaluate the Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer With Peritoneal Metastasis (PIPAC-OVPAC 1/2a)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tolerance, safety, efficacy, and pharmacokinetics of pressurized intraperitoneal aerosol chemotherapy (PIPAC) with paclitaxel in patients with platinum-resistant recurrent ovarian cancer and peritoneal carcinomatosis.

Detailed description

The Study Design is an interventional, non-randomized, sequential Phase 1/2a trial, where patients with platinum-resistant recurrent ovarian cancer(PROC) and radiologically confirmed peritoneal carcinomatosis will be enrolled. All patients included in this study will receive PIPAC, laparoscopic aerosolization of paclitaxel under 12 mmHg pressure at 6-week intervals (up to 9 cycles) for treating PROC with peritoneal metastasis.

Conditions

• Ovarian Neoplasms
• Peritoneal Neoplasms

Interventions

Type	Name	Description
DRUG	Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel	All patients enrolled in this study receive PIPAC using paclitaxel under 12 mmHg at 6 weeks intervals (up to 9 cycles) 1. Phase 1 Design 1. Dose Escalation: Standard 3+3 design across 5 paclitaxel cohorts (20 → 40 → 67 → 100 → 140 mg/m²) using modified Fibonacci increments (100%, 67%, 50%, 40%). 2. Maximum tolerated dose(MTD) Determination * If ≥2/6 patients in cohort χ experience dose limiting toxicities(DLTs; Grade ≥3 toxicity per CTCAE v5.0, excluding manageable pain) and ≤1/6 in cohort χ-1, MTD = χ-1. * If no DLTs at 140 mg/m², Phase 1 concludes. 3. Dose Reduction * DLTs in 20 mg/m² trigger de-escalation to 10 mg/m². * If ≤1/6 DLTs in 10 mg/m² → RP2D; ≥2/6 DLTs → trial termination. 2. Phase 2 Design : Evaluates efficacy/safety of PIPAC at the RP2D in 23 patients, adjusting for 5-17% laparoscopic access failure.

Timeline

• Start date: 2026-01-01
• Primary completion: 2030-04-30
• Completion: 2030-08-31
• First posted: 2025-12-09
• Last updated: 2025-12-09