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Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

NCT07074353 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-07-25

No results posted yet for this study

Summary

This study enrolled patients with locally advanced rectal cancer. The experimental group received irinotecan liposomes combined with standard total neoadjuvant therapy (TNT), while the control group received standard TNT. The study endpoints were the complete response rate (cCR + pCR), 3-year event-free survival (EFS) rate, and overall survival (OS). The aim was to compare the efficacy and safety of irinotecan liposomes combined with or without standard TNT.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

NALIRI

Irinotecan liposomes

RADIATION

LCRT

Long-course concurrent chemoradiotherapy

DRUG

FOLFOX

Fluorouracil/Leucovorin, Oxaliplatin (5-FU/LV, OX)

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

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
2025-07-20
Primary Completion
2028-04-01
Completion
2030-07-01

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 NCT07074353 on ClinicalTrials.gov