NCT06385418

Fluorouracil Treatment Via Colon for Colorectal Cancer

Fluorouracil Treatment Via Colon for Colorectal Cancer: an Exploratory Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Colonic local administration of fluorouracil with enhanced adhesion	Fluorouracil is administered via the colon as an injectable solution at a dose of 500 mg per day for 6 days, along with poloxamer 407 and poloxamer 188 used as thermosensitive hydrogel to enhance adhesion.

Timeline

• Start date: 2024-05-16
• Primary completion: 2028-05-01
• Completion: 2029-05-01
• First posted: 2024-04-26
• Last updated: 2024-06-26

Locations

1 site across 1 country: China