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

Sponsor
Rui-hua Xu, MD, PhD
Study ID
NCT06501664
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • liposomal irinotecan — DRUG
    Liposomal irinotecan 70 mg/m²
  • 5-FU — DRUG
    5-FU 400 mg/m² bolus then 2400 mg/m2 over 46 h
  • LV — DRUG
    LV 400 mg/m²
  • Irinotecan — DRUG
    Irinotecan 180 mg/m²

Study Details

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).

Key Dates

Start date
Aug 1, 2024
Status verified
Jul 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Experimental Group
    liposomal irinotecan+5-FU/LV q2w
  • Active Comparator: Control group
    Irinotecan q2w or irinotecan+5-FU/LV q2w

Primary Outcome Measure

Overall survival [ Time Frame: 1 year ]

Central Contacts

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