drugset / Trial / NCT04943653

Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

NCT04943653

Phase 1/2 Unknown 61 enrolled Seoul St. Mary's Hospital
NaSingle-groupOpen-labelTreatment

Summary

IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis. Study hypotheses: Intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.

Timeline

Start
2021-06-08
Primary completion
2023-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 20 mg/m2 Other
Subject Paclitaxel Small molecule 40 mg/m2 Other
Subject Paclitaxel Small molecule 60 mg/m2 Other
Background Capecitabine Small molecule 2000 mg/m2
Background Oxaliplatin Small molecule 100 mg/m2 Intravenous