Clinical trial · Interventional
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy
- 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)
Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results. This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer Stage IV | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Intraperitoneal Paclitaxel | — | UNRESOLVED | — |
| mFOLFOX6 | — | UNRESOLVED | — |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFOX6 regimen | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gastric Cancer with Peritoneal Carcinomatosis
- description
- Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
- interventionNames
- Drug: Paclitaxel
- Drug: mFOLFOX6 regimen
Primary outcomes (2)
- measure
- Dose determination (Phase 1)
- timeFrame
- 1 Year
- description
- Dosage determination of Intraperitoneal Paclitaxel
- measure
- Overall survival (Phase 2)
- timeFrame
- 1 Year
- description
- 1 year Overall survival with determined dose from Phase 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven adenocarcinoma of gastric origin, primary or recurrent * Identification of Peritoneal seeding by CT or diagnostic laparoscopy * Patients confirmed to receive mFOLFOX6 on multidisciplinary outpatient clinic * No previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer * Labs 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 * Her-2 negative on endoscopic biopsy * Age ≧ 20, \< 80 * Signed Informed consent form 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 * Patients refusing treatment
References
Publications (0)
Data not yet available