At a glance
ClinicalIndex Comparison RecordPhase 3Unknown· 240 target
Drug / intervention
S1 +2 moredrug
Likely dose
S1 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Squamous Cell Carcinoma (ESWN 01 Trial): a Phase 3, Prospective,Multicenter, Randomised Study
In Brief
A Phase 3 clinical trial evaluating S1, S-1, and 1 other intervention for Esophageal Neoplasms. Targeting 240 participants across 13 sites.
Detailed Summary
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the progression free survival and safety of irinotecan plus S1 versus S1 alone in the patients with previously treated advanced esophageal cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Neoplasms
CountriesChina
Collaborators--
Timeline
Phase 3UnknownOverdue
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedDec 2014
Primary CompletionDec 2016
Study CompletionJun 2017
TodayJul 2026
First PostedDec 18, 2014
Enrollment StartDec 1, 2014
Primary CompletionDec 1, 2016
Study CompletionJun 1, 2017
TodayJul 1, 2026
Enrollment to primary: 2 yearsPosted 11.5 years ago
Interventions
S1drug
S1 80mg to 120 mg per day on Days 1-14, every 21 days
S-1drug
S1 80mg to 120 mg per day on Days 1-10, every 14 days;
irinotecandrug
irinotecan 160mg/m2 d1, every 14 days