NCT04675983

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

A Randomized, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Sintilimab Combined With Ramucirumab as Compared to Chemotherapy for the First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (ORIENT-106)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, multicenter, phase 3 study to evaluate the efficacy and safety of sintilimab combined with ramucirumab as compared to stand of care chemotherapy for the first-line treatment of PD-L1 positive, unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. The primary endpoint of this study is OS of the ITT population.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	Administered IV
DRUG	Ramucirumab	Administered IV
DRUG	Cisplatin	Administered IV
DRUG	5-fluorouracil	Administered IV
DRUG	Oxaliplatin	Administered IV
DRUG	Capecitabine	Administered orally

Timeline

• Start date: 2021-03-10
• Primary completion: 2023-02-12
• Completion: 2023-02-12
• First posted: 2020-12-19
• Last updated: 2023-03-02

Locations

1 site across 1 country: China