Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis

Seoul National University

Status and phase: Unknown; Phase 1

Conditions: Stomach Neoplasm; Peritoneal Metastases

Treatments: Procedure: Pressurized Intraperitoneal Aerosol Chemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04913662

SNUBH_PIPAC_PTX

Details and patient eligibility

About

This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically diagnosed as gastric adenocarcinoma
• Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
• HER-2 negative tumor
• Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
• Absolute Neutrophil Count: ≧ 1,500/mm³
• Hemoglobin level: ≧ 8.0g/dL
• Platelet Count: ≧ 10×104/mm³
• AST (GOT), ALT (GPT): ≦ 100U/L
• Total Bilirubin: ≦ 2.0mg/dL
• Creatinine Clearance (CCl): ≧ 50mL/min
• ECOG 0 - 2

Exclusion criteria

• Patients with other major medical disease or malignant tumors other than gastric cancer
• Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
• Pregnant, breast-feeding women or with birth plan
• History of gastrointestinal surgery
• Patients refusing treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

PIPAC Paclitaxel with FOLFOX

Experimental group

Description:

PIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)

Treatment:

Procedure: Pressurized Intraperitoneal Aerosol Chemotherapy