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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age19-85
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age: Women aged 19-85 years.

Diagnosis: Histologically confirmed ovarian, fallopian tube, or peritoneal cancer.

Refractory: Disease progression during platinum-based chemotherapy.

Resistant: Progression within 6 months (24 weeks) post-platinum therapy.

Disqualifiers

≥2 distant metastases (excluding retroperitoneal lymph nodes, pleural effusion, and localized skin metastases).

Contraindications to paclitaxel per approved domestic labeling.

Hypersensitivity history to paclitaxel or PIPAC devices.

NYHA Class ≥II heart failure

Trial design

Treatments tested in this trial

  • Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel

Treatment groups

53 Participants
are divided into 1 treatment group

Locations

This trial has no locations