Clinical Trials Directory

Trials / Completed

CompletedNCT03116152

Study of IBI308 With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment

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)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
190 (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

Detailed description

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)

Conditions

Interventions

TypeNameDescription
BIOLOGICALIBI308IBI308 200mg Intravenous drip every three weeks;
DRUGpaclitaxel/ irinotecanpaclitaxel 175mg/㎡ Intravenous drip every three weeks or irinotecan 180mg/㎡ Intravenous drip every two weeks

Timeline

Start date
2017-05-10
Primary completion
2019-10-02
Completion
2019-10-02
First posted
2017-04-14
Last updated
2021-02-03
Results posted
2021-01-19

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03116152. Inclusion in this directory is not an endorsement.