NCT04943653

Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

Phase I,II Study of First Line Intraperitoneal Paclitaxel With Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomach Neoplasms
• Paclitaxel
• Peritoneal Metastases

Interventions

Type	Name	Description
DRUG	Paclitaxel	intraperitoneal paclitaxel 20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I) recommended dose (phase II)

Timeline

• Start date: 2021-06-08
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2021-06-29
• Last updated: 2021-07-06

Locations

1 site across 1 country: South Korea