drugset / Trial / NCT04675983

A Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106)

NCT04675983 ↗

Phase 3 Terminated 36 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate the efficacy and safety of sintilimab plus ramucirumab compared to stand of care first-line chemotherapy in participants with advanced gastric or esophagogastric adenocarcinoma.

Timeline

Start
2021-03-10
Primary completion
2023-02-12
Completion
2023-02-12

Outcome

Outcome not reported

Stopped (Business): “Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule — Oral
Comparator Cisplatin Other / unclassified — Intravenous
Comparator Oxaliplatin Small molecule — Intravenous
Subject Ramucirumab Monoclonal antibody — Intravenous
Subject Sintilimab Monoclonal antibody — Intravenous
Comparator fluorouracil Small molecule — Intravenous