NCT06894797

Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer.

The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined with Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Concurrent Chemoradiotherapy（Radiation + Capecitabine）	Capecitabine 825 mg/m\^2 Po BlD, Monday-Friday, on days of radiation treatment only, throughout the duration of RT Radiation：45-50Gy/25fractions/5 weeks，5fractions/week
DRUG	irinotecan hydrochloride liposome injection	Irinotecan hydrochloride liposome injection (50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
DRUG	Oxaliplatin	Oxaliplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
DRUG	5-FU	5-FU (2400mg/m\^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: China