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IP Paclitaxel + XELOX in Advanced Gastric Cancer with Peritoneal Metastasis
NCT04943653Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2021
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- Seoul St. Mary's Hospital
- Modality
- Small Molecules
- Drugs
- paclitaxel
- Conditions
- gastric cancer (GC)
01
Overview
Phase 2, open-label, single-arm trial of paclitaxel in gastric cancer (GC), sponsored by Seoul St. Mary's Hospital. Primary endpoint: 6-month Progression Free Survival. Started Jun 2021; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Intraperitoneal paclitaxel + XELOX
Intraperitoneal paclitaxel combined with systemic Capecitabine and Oxaliplatin
03
Who it enrols
Patients with pathologically proven primary gastric adenocarcinoma and peritoneal metastasis, ECOG 0-1, and adequate organ function. Excludes HER2 positive, DPD deficiency, and prior anticancer therapy within 6 months.
04
Endpoints
Primary
6-month Progression Free Survival
Secondary
1-year Overall Survival
Objective Response Rate
Conversion surgery rate
Ascites response
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