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

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Capecitabine; Fluorouracil; Oxaliplatin; Ramucirumab

Criteria

Inclusion criteria

• Have a histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma

• With HER2 negative and PD-L1 positive tumor tissue

• Have fresh or archival tumor tissue samples within 6 months for PD-L1 expression test.

• Age ≥18 and ≤75 years

• Diagnosed as unresectable locally advanced or metastatic stage

Exclusion criteria

• Have received any prior palliative systemic treatment for advanced gastric or gastroesophageal junction adenocarcinoma.

• Known to have central nervous system metastases, cancerous meningitis, or bone metastases with a risk of paraplegia

• Known bone metastasis with a risk of paraplegia.

• Have any ascites that requires intervention.

• With bilateral medium pleural effusion or unilateral large pleural effusion leading to respiratory symptoms