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

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT06894797
Status
Recruiting
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Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Concurrent Chemoradiotherapy（Radiation + Capecitabine） — RADIATION
    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
  • irinotecan hydrochloride liposome injection — DRUG
    Irinotecan hydrochloride liposome injection (50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
  • Oxaliplatin — DRUG
    Oxaliplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
  • 5-FU — DRUG
    5-FU (2400mg/m\^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle.

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Mar 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy
    Patients will receive Concurrent Chemoradiotherapy（Radiation + Capecitabine） followed by NALIRIFOX Concurrent Chemoradiotherapy：5 Weeks in total NALIRIFOX：8 Weeks in total
  • Experimental: Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy
    Patients will receive NALIRIFOX followed by Concurrent Chemoradiotherapy（Radiation + Capecitabine） Concurrent Chemoradiotherapy：5 Weeks in total NALIRIFOX：8 Weeks in total

Primary Outcome Measure

Pathological complete response rate [ Time Frame: From baseline up to approximately 3 months ]

Central Contacts

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