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
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 400 mg/m² bolus then 2400 mg/m2 over 46 h
- DRUG
-
LV
LV 400 mg/m²
- DRUG
-
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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