Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC

NCT06501664 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2024-07-15

No results posted yet for this study

Summary

The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).

Conditions

  • Esophageal Cancer

Interventions

DRUG

liposomal irinotecan

Liposomal irinotecan 70 mg/m²

DRUG

5-FU

5-FU 400 mg/m² bolus then 2400 mg/m2 over 46 h

DRUG

LV

LV 400 mg/m²

DRUG

Irinotecan

Irinotecan 180 mg/m²

Sponsors & Collaborators

  • Rui-hua Xu, MD, PhD

    lead OTHER

Principal Investigators

  • Ruihua Xu, Professor · Yat-sen University Cancer Center

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
2024-08-01
Primary Completion
2026-11-30
Completion
2027-11-30

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Entities

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 NCT06501664 on ClinicalTrials.gov