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

NCT06894797 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-03-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Yongheng Li, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894797 on ClinicalTrials.gov