CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 190 enrolled
Drug / intervention
IBI308 +1 morebiological
Likely dose
IBI308 200mgfrom 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.

Search/NCT03116152
NCT03116152Phase 2Completed

Efficacy and Safety Evaluation of IBI308 Versus Paclitaxel/Irinotecan in Patients With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment: a Randomized, Open-label, Multicenter, Phase 2 Study (ORIENT-2)

Innovent Biologics (Suzhou) Co. Ltd.·interventional·Posted Apr 14, 2017·Updated Feb 3, 2021

In Brief

A Phase 2 clinical trial evaluating IBI308 and paclitaxel/ irinotecan for Esophageal Squamous Cell Carcinoma. Completed, enrolled 190 participants across 1 site.

Detailed Summary

Efficacy and safety evaluation of IBI308 versus paclitaxel/irinotecan in patients with advanced/metastatic esophageal squamous cell carcinoma after failure of first-line treatment: a randomized, open-label, multicenter, phase 2 study

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 14, 2017
Enrollment StartMay 10, 2017
Primary CompletionOct 2, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.2 years ago

Interventions

IBI308biological

IBI308 200mg Intravenous drip every three weeks;

paclitaxel/ irinotecandrug

paclitaxel 175mg/㎡ Intravenous drip every three weeks or irinotecan 180mg/㎡ Intravenous drip every two weeks