Clinical trial · Interventional
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
NCT04913662CI-TRIAL-00052121unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Metastases | — | UNRESOLVED | — |
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pressurized Intraperitoneal Aerosol Chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PIPAC Paclitaxel with FOLFOX
- description
- PIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
- interventionNames
- Procedure: Pressurized Intraperitoneal Aerosol Chemotherapy
Primary outcomes (1)
- measure
- Recommended dose
- timeFrame
- Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)
- description
- Recommended dose of paclitaxel for a phase II trial
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.