Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC
ConditionEsophageal Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRui-hua Xu, MD, PhD
About this trial
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).
Eligibility criteria
Qualifiers
Age: 18-75 years old.
Unresectable esophageal squamous cell carcinoma confirmed by histopathology and/or cytology.
Failure or intolerance to first-line treatment.
At least one measurable lesion (according to RECIST v1.1).
Disqualifiers
Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.
Received irinotecan/irinotecan liposome based therapy in the first line.
Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
Active HIV infection.
Trial design
Treatments tested in this trial
- liposomal irinotecan
- 5-FU
- LV
- Irinotecan
Treatment groups
360 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Rui-hua Xu, MD, PhD
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov