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

Last updated: June 1, 2021
Sponsor: Seoul National University Bundang Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Digestive System Neoplasms

Stomach Cancer

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT04913662
SNUBH_PIPAC_PTX
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 18
Study Start date:
April 26, 2021
Estimated Completion Date:
June 30, 2022

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggi-do 13620
    Korea, Republic of

    Active - Recruiting

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